Cardiovascular

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Code	Device name	Class	21 CFR	510(k) (3y)
BYS	Oxygenator, Long Term Support Greater Than 6 Hours	Class 2	21 CFR 870.4100	3
DPS	Electrocardiograph	Class 2	21 CFR 870.2340	576
DPT	Probe, Blood-Flow, Extravascular	Class 2	21 CFR 870.2120	48
DPW	Flowmeter, Blood, Cardiovascular	Class 2	21 CFR 870.2100	138
DPZ	Oximeter, Ear	Class 2	21 CFR 870.2710	11
DQA	Oximeter	Class 2	21 CFR 870.2700	726
DQB	Phlebograph, Impedance	Class 2	21 CFR 870.2750	3
DQC	Phonocardiograph	Class 1	21 CFR 870.2390	18
DQD	Stethoscope, Electronic	Class 2	21 CFR 870.1875	156
DQE	Catheter, Oximeter, Fiber-Optic	Class 2	21 CFR 870.1230	19
DQF	Actuator, Syringe, Injector Type	Class 2	21 CFR 870.1670	3
DQG	Microsphere, Trace	Class 3	21 CFR 870.1360
DQH	Cardiograph, Apex (Vibrocardiograph)	Class 2	21 CFR 870.2310	1
DQI	Withdrawal/Infusion Pump	Class 2	21 CFR 870.1800	9
DQK	Computer, Diagnostic, Programmable	Class 2	21 CFR 870.1425	437
DQO	Catheter, Intravascular, Diagnostic	Class 2	21 CFR 870.1200	501
DQP	Kit, Balloon Repair, Catheter	Class 3	21 CFR 870.1350
DQR	Cannula, Catheter	Class 2	21 CFR 870.1300	25
DQT	Occluder, Catheter Tip	Class 2	21 CFR 870.1370	12
DQX	Wire, Guide, Catheter	Class 2	21 CFR 870.1330	766
DQY	Catheter, Percutaneous	Class 2	21 CFR 870.1250	895
DRA	Catheter, Steerable	Class 2	21 CFR 870.1280	42
DRB	Stylet, Catheter	Class 2	21 CFR 870.1380	28
DRC	Trocar	Class 2	21 CFR 870.1390	51
DRE	Dilator, Vessel, For Percutaneous Catheterization	Class 2	21 CFR 870.1310	105
DRF	Catheter, Electrode Recording, Or Probe, Electrode Recording	Class 2	21 CFR 870.1220	185
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Class 2	21 CFR 870.2910	192
DRI	Monitor, Line Isolation	Class 1	21 CFR 870.2620	4
DRJ	System, Signal Isolation	Class 1	21 CFR 870.2600	4
DRK	Dc-Defibrillator, High Energy, (Including Paddles)	Class 3	21 CFR 870.5300	1
DRL	Tester, Defibrillator	Class 2	21 CFR 870.5325	19
DRM	Compressor, Cardiac, External	Class 2	21 CFR 870.5200	45
DRN	Device, Counter-Pulsating, External	Class 2	21 CFR 870.5225	34
DRO	Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)	Class 2	21 CFR 870.5550	84
DRP	Tourniquet, Automatic Rotating	Class 2	21 CFR 870.5925
DRQ	Amplifier And Signal Conditioner, Transducer Signal	Class 2	21 CFR 870.2060	27
DRR	Amplifier And Signal Conditioner, Biopotential	Class 2	21 CFR 870.2050	24
DRS	Transducer, Blood-Pressure, Extravascular	Class 2	21 CFR 870.2850	148
DRT	Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	Class 2	21 CFR 870.2300	339
DRW	Adaptor, Lead Switching, Electrocardiograph	Class 2	21 CFR 870.2350	8
DRX	Electrode, Electrocardiograph	Class 2	21 CFR 870.2360	329
DRY	Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass	Class 2	21 CFR 870.4330	47
DRZ	Oscillometer	Class 2	21 CFR 870.2675
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Class 2	21 CFR 870.2900	105
DSB	Plethysmograph, Impedance	Class 2	21 CFR 870.2770	115
DSF	Recorder, Paper Chart	Class 1	21 CFR 870.2810	87
DSH	Recorder, Magnetic Tape, Medical	Class 2	21 CFR 870.2800	195
DSI	Detector And Alarm, Arrhythmia	Class 2	21 CFR 870.1025	398
DSJ	Alarm, Blood-Pressure	Class 2	21 CFR 870.1100	6
DSK	Computer, Blood-Pressure	Class 2	21 CFR 870.1110	77
DSM	Alarm, Leakage Current, Portable	Class 1	21 CFR 870.2640	1
DSP	System, Balloon, Intra-Aortic And Control	Class 2	21 CFR 870.3535	162
DSR	Stimulator, Carotid Sinus Nerve	Class 3	21 CFR 870.3850
DSS	Clip, Vascular	Class 2	21 CFR 870.3250	8
DST	Clip, Vena-Cava	Class 2	21 CFR 870.3260	1
DSW	Bag, Polymeric Mesh, Pacemaker	Class 1	21 CFR 870.3650
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Class 2	21 CFR 870.3450	188
DSZ	Pacemaker Battery	Class 3	21 CFR 870.3610
DTA	Tester, Pacemaker Electrode Function	Class 2	21 CFR 870.3720	10
DTB	Permanent Pacemaker Electrode	Class 3	21 CFR 870.3680	487
DTC	Analyzer, Pacemaker Generator Function	Class 2	21 CFR 870.3630	30
DTD	Pacemaker Lead Adaptor	Class 2	21 CFR 870.3620	103
DTE	Pulse-Generator, Pacemaker, External	Class 2	21 CFR 870.3600	65
DTF	Tools, Pacemaker Service	Class 1	21 CFR 870.3730	2
DTG	Magnet, Test, Pacemaker	Class 1	21 CFR 870.3690	5
DTI	Sizer, Heart-Valve, Prosthesis	Class 1	21 CFR 870.3945	7
DTJ	Holder, Heart-Valve, Prosthesis	Class 1	21 CFR 870.3935	12
DTK	Filter, Intravascular, Cardiovascular	Class 2	21 CFR 870.3375	83
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Class 2	21 CFR 870.4290	137
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Class 2	21 CFR 870.4260	96
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Class 2	21 CFR 870.4400	169
DTP	Defoamer, Cardiopulmonary Bypass	Class 2	21 CFR 870.4230	34
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	Class 2	21 CFR 870.4220	52
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Class 2	21 CFR 870.4240	91
DTS	Sucker, Cardiotomy Return, Cardiopulmonary Bypass	Class 2	21 CFR 870.4420	9
DTW	Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass	Class 2	21 CFR 870.4340	17
DTX	Gas Control Unit, Cardiopulmonary Bypass	Class 2	21 CFR 870.4300	10
DTY	Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass	Class 2	21 CFR 870.4410	8
DTZ	Oxygenator, Cardiopulmonary Bypass	Class 2	21 CFR 870.4350	254
DWA	Control, Pump Speed, Cardiopulmonary Bypass	Class 2	21 CFR 870.4380	37
DWB	Pump, Blood, Cardiopulmonary Bypass, Roller Type	Class 2	21 CFR 870.4370	21
DWC	Controller, Temperature, Cardiopulmonary Bypass	Class 2	21 CFR 870.4250	30
DWD	Suction Control, Intracardiac, Cardiopulmonary Bypass	Class 2	21 CFR 870.4430	15
DWE	Tubing, Pump, Cardiopulmonary Bypass	Class 2	21 CFR 870.4390	21
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Class 2	21 CFR 870.4210	401
DWJ	System, Thermal Regulating	Class 2	21 CFR 870.5900	161
DWM	Apparatus, Suction, Patient Care	Class 2	21 CFR 870.5050	19
DWP	Dilator, Vessel, Surgical	Class 2	21 CFR 870.4475	20
DWQ	Stripper, Vein, External	Class 2	21 CFR 870.4885	8
DWS	Instruments, Surgical, Cardiovascular	Class 1	21 CFR 870.4500	71
DWX	Stripper, Artery, Intraluminal	Class 2	21 CFR 870.4875	14
DWZ	Device, Biopsy, Endomyocardial	Class 2	21 CFR 870.4075	23
DXC	Clamp, Vascular	Class 2	21 CFR 870.4450	205
DXE	Catheter, Embolectomy	Class 2	21 CFR 870.5150	74
DXF	Catheter, Septostomy	Class 2	21 CFR 870.5175	21
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Class 2	21 CFR 870.1435	177
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Class 2	21 CFR 870.2920	297
DXJ	Display, Cathode-Ray Tube, Medical	Class 2	21 CFR 870.2450	78
DXK	Echocardiograph	Class 2	21 CFR 870.2330	78
DXL	Injector, Indicator	Class 2	21 CFR 870.1660	3
DXM	Densitometer	Class 2	21 CFR 870.1450	2
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Class 2	21 CFR 870.1130	1222
DXO	Transducer, Pressure, Catheter Tip	Class 2	21 CFR 870.2870	64
DXP	Transducer, Vessel Occlusion	Class 2	21 CFR 870.2890	2
DXQ	Blood Pressure Cuff	Class 2	21 CFR 870.1120	199
DXR	Ballistocardiograph	Class 2	21 CFR 870.2320	5
DXS	Gauge, Pressure, Coronary, Cardiopulmonary Bypass	Class 2	21 CFR 870.4310	13
DXT	Injector And Syringe, Angiographic	Class 2	21 CFR 870.1650	210
DXW	System, Phonocatheter, Intracavitary	Class 2	21 CFR 870.1270	5
DXX	System, Catheter Control, Steerable	Class 2	21 CFR 870.1290	34
DXY	Implantable Pacemaker Pulse-Generator	Class 3	21 CFR 870.3610	461
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Class 2	21 CFR 870.3470	90
DYB	Introducer, Catheter	Class 2	21 CFR 870.1340	706
DYC	Vectorcardiograph	Class 2	21 CFR 870.2400	4
DYE	Replacement Heart-Valve	Class 3	21 CFR 870.3925
DYF	Prosthesis, Vascular Graft, Of Less Then 6mm Diameter	Class 2	21 CFR 870.3450	21
DYG	Catheter, Flow Directed	Class 2	21 CFR 870.1240	99
IZQ	Injector, Contrast Medium, Automatic	Class 2	21 CFR 870.1650	23
JOD	Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass	Class 2	21 CFR 870.4270	12
JOM	Plethysmograph, Photoelectric, Pneumatic Or Hydraulic	Class 2	21 CFR 870.2780	53
JON	Transducer, Apex Cardiographic	Class 2	21 CFR 870.2840
JOO	Transducer, Heart Sound	Class 2	21 CFR 870.2860
JOP	Transducer, Ultrasonic	Class 2	21 CFR 870.2880	72
JOQ	Generator, Pulse, Pacemaker, External Programmable (For Electrophysiol	Class 2	21 CFR 870.1750	18
JOR	Generator, Pulsatile Flow, Cardiopulmonary Bypass	Class 3	21 CFR 870.4320
JOW	Sleeve, Limb, Compressible	Class 2	21 CFR 870.5800	352
KFJ	Materials, Repair Or Replacement, Pacemaker	Class 3	21 CFR 870.3710	3
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Class 2	21 CFR 870.4360	84
KRA	Catheter, Continuous Flush	Class 2	21 CFR 870.1210	175
KRB	Probe, Thermodilution	Class 2	21 CFR 870.1915	37
KRC	Tester, Electrode, Surface, Electrocardiographic	Class 2	21 CFR 870.2370	11
KRD	Device, Vascular, For Promoting Embolization	Class 2	21 CFR 870.3300	132
KRE	Analyzer, Pacemaker Generator Function, Indirect	Class 2	21 CFR 870.3640	13
KRF	Charger, Pacemaker	Class 1	21 CFR 870.3670
KRG	Programmer, Pacemaker	Class 3	21 CFR 870.3700	25
KRH	Ring, Annuloplasty	Class 2	21 CFR 870.3800	75
KRI	Accessory Equipment, Cardiopulmonary Bypass	Class 1	21 CFR 870.4200	42
KRJ	Filter, Prebypass, Cardiopulmonary Bypass	Class 2	21 CFR 870.4280	24
KRK	Manometer, Blood-Pressure, Venous	Class 2	21 CFR 870.1140	9
KRL	Detector, Bubble, Cardiopulmonary Bypass	Class 2	21 CFR 870.4205	14
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Class 2	21 CFR 870.5300	166
LDE	Stethoscope, Manual	Class 1	21 CFR 870.1875	28
LDF	Electrode, Pacemaker, Temporary	Class 2	21 CFR 870.3680	130
LHX	Trousers, Anti-Shock	Class 2	21 CFR 870.5800	4
LIT	Catheter, Angioplasty, Peripheral, Transluminal	Class 2	21 CFR 870.1250	403
LIX	Aid, Cardiopulmonary Resuscitation	Class 2	21 CFR 870.5210	17
LOX	Catheters, Transluminal Coronary Angioplasty, Percutaneous	Class 2	21 CFR 870.5100	88
LXN	Probe, Test, Heart-Valve	Class 1	21 CFR 870.4500	2
MAB	Marker, Cardiopulmonary Bypass (Vein Marker)	Class 2	21 CFR 870.3450	3
MAL	Graft, Vascular, Synthetic/Biologic Composite	Class 2	21 CFR 870.3450	6
MAV	Syringe, Balloon Inflation	Class 2	21 CFR 870.1650	57
MCW	Catheter, Peripheral, Atherectomy	Class 2	21 CFR 870.4875	146
MFX	Vessel Guard Or Cover, To Facilitate Revision Surgeries	Class 2	21 CFR 870.3470	2
MFY	Endothelial Cell Harvesting Kit	Class 2	21 CFR 870.4075	1
MGZ	Valvulotome	Class 2	21 CFR 870.4885	27
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Class 2	21 CFR 870.1025	429
MJJ	Cpb Check Valve, Retrograde Flow, In-Line	Class 2	21 CFR 870.4400	9
MJN	Catheter, Intravascular Occluding, Temporary	Class 2	21 CFR 870.4450	90
MKJ	Automated External Defibrillators (Non-Wearable)	Class 3	21 CFR 870.5310	228
MLC	Monitor, St Segment	Class 2	21 CFR 870.2340	2
MLD	Monitor, St Segment With Alarm	Class 2	21 CFR 870.1025	14
MLN	Electrode, Electrocardiograph, Multi-Function	Class 2	21 CFR 870.2360
MLO	Electrocardiograph, Ambulatory, With Analysis Algorithm	Class 2	21 CFR 870.2800	32
MMX	Device, Percutaneous Retrieval	Class 2	21 CFR 870.5150	32
MNJ	Valve, Pressure Relief, Cardiopulmonary Bypass	Class 2	21 CFR 870.4400	2
MNW	Analyzer, Body Composition	Class 2	21 CFR 870.2770	79
MOF	Guide, Wire, Catheter, Neurovasculature	Class 2	21 CFR 870.1330	44
MOP	Rotator, Prosthetic Heart Valve	Class 1	21 CFR 870.3935	4
MPC	Atrial Defibrillator	Class 3	21 CFR 870.5300
MPD	Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator	Class 2	21 CFR 870.5300	3
MPE	Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac P	Class 2	21 CFR 870.5550	1
MSX	System, Network And Communication, Physiological Monitors	Class 2	21 CFR 870.2300	119
MTD	Catheter, Intracardiac Mapping, High-Density Array	Class 2	21 CFR 870.1220	34
MUD	Oximeter, Tissue Saturation	Class 2	21 CFR 870.2700	74
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarm	Class 2	21 CFR 870.2300	308
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Class 2	21 CFR 870.2800	62
MWS	Stabilizer, Heart	Class 1	21 CFR 870.4500	4
MXC	Recorder, Event, Implantable Cardiac, (Without Arrhythmia Detection)	Class 2	21 CFR 870.2800	23
MXD	Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection)	Class 2	21 CFR 870.1025	34
MZY	Graft, Vascular, Stainless Steel Tunneler	Class 2	21 CFR 870.3450
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Class 2	21 CFR 870.3300	8
NCX	System, Hypothermia, Intravenous, Cooling	Class 2	21 CFR 870.5900	26
NDQ	System, Catheter Or Guidewire, Steerable (Magnetic)	Class 2	21 CFR 870.1290	2
NFA	Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection	Class 2	21 CFR 870.1250	22
NHW	Electrode, Pacing And Cardioversion, Temporary, Epicardial	Class 2	21 CFR 870.3680	2
NKO	System, Balloon, Intra-Aortic And Control, Reprocessed	Class 3	21 CFR 870.3535
NKP	Injector, Contrast Medium, Automatic, Reprocessed	Class 2	21 CFR 870.1650
NKQ	Guidewire, Catheter, Reprocessed	Class 2	21 CFR 870.1330
NKR	System, Catheter Control, Reprocessed	Class 2	21 CFR 870.1290
NKS	Catheter, Steerable, Reprocessed	Class 2	21 CFR 870.1280
NKT	Injector And Syringe, Angiographic, Reprocessed	Class 2	21 CFR 870.1650
NKU	Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed	Class 2	21 CFR 870.1650	1
NKW	Actuator, Syringe, For Injector, Reprocessed	Class 2	21 CFR 870.1670
NLF	Oximeter, Reprocessed	Class 2	21 CFR 870.2700	27
NLG	Catheter, Intracardiac Mapping, High-Density, Reprocessed	Class 2	21 CFR 870.1220	3
NLH	Catheter, Recording, Electrode, Reprocessed	Class 2	21 CFR 870.1220	70
NLI	Catheter, Angiography, Reprocessed	Class 2	21 CFR 870.1200	1
NLJ	Stripper, Vein, External, Reprocessed	Class 2	21 CFR 870.4885
NMB	Catheter, Oximeter, Fiber Optic, Reprocessed	Class 2	21 CFR 870.1230
NMD	Oximeter, Tissue Saturation, Reprocessed	Class 2	21 CFR 870.2700	2