Cardiovascular

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Code	Device name	Class	21 CFR	510(k) (3y)
NMF	Clamp, Vascular, Reprocessed	Class 2	21 CFR 870.4450	3
NMK	Trocar, Reprocessed	Class 2	21 CFR 870.1390	1
NMM	Catheter, Angioplasty, Peripheral, Transluminal, Reprocessed	Class 2	21 CFR 870.1250
NPG	Catheter, Infusion, Syringe	Class 2	21 CFR 870.1210	1
NPP	Reprocessed Blood Pressure Cuff	Class 2	21 CFR 870.1120	1
NQG	Stabilizer, Heart, Non-Compression, Reprocessed	Class 1	21 CFR 870.4500	3
NQH	Sensor, Pressure, Aneurysm, Implantable	Class 2	21 CFR 870.2855	5
NRY	Catheter, Thrombus Retriever	Class 2	21 CFR 870.1250	114
NSA	Over-The-Counter Automated External Defibrillator	Class 3	21 CFR 870.5310	1
NTE	Temporary Carotid Catheter For Embolic Capture	Class 2	21 CFR 870.1250	36
NUI	Ultrasound, Infusion, System	Class 2	21 CFR 870.1200	4
NVM	Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon	Class 2	21 CFR 870.1250	5
NZE	Hyperthermia Monitor	Class 2	21 CFR 870.5900	6
OAC	Plethysmograph, Air Displacement For Body Composition Analysis	Class 2	21 CFR 870.2770	3
OBH	Monitor, Extracellular Fluid, Lymphedema, Extremity	Class 2	21 CFR 870.2770	10
OBI	Catheter, Pressure Monitoring, Cardiac	Class 2	21 CFR 870.1200	1
OBJ	Catheter, Ultrasound, Intravascular	Class 2	21 CFR 870.1200	79
OCH	Oximeter, Infrared, Sporting, Aviation	Class 2	21 CFR 870.2700
OCR	Lung Sound Monitor	Class 2	21 CFR 870.1875	3
OED	Antimicrobial Blood Pressure Cuff	Class 2	21 CFR 870.1120	2
OEQ	Angiography/Angioplasty Kit	Class 2	21 CFR 870.1650
OER	Angioscopic Valvulotome Kit	Class 2	21 CFR 870.1650
OES	Cardiac Catheterization Kit	Class 2	21 CFR 870.1200
OET	Cardioplegia Solution Administration Kit	Class 2	21 CFR 870.4240
OEU	Cardiopulmonary Bypass Catheter Kit	Class 2	21 CFR 870.4210
OEX	Cardiovascular Catheter Sheath Introducer Kit	Class 2	21 CFR 870.1340
OEZ	Cardiovascular Procedure Kit	Class 2	21 CFR 870.1200
OFA	Cardiovascular Surgical Instruments Tray	Class 1	21 CFR 870.4500
OFB	Catheter Guide Wire Kit	Class 2	21 CFR 870.1330
OFC	Catheter Introducer Kit	Class 2	21 CFR 870.1340	1
OFD	Catheter Introducer Kit	Class 2	21 CFR 870.1340
OFE	Central Venous Blood Pressure Kit	Class 2	21 CFR 870.1140
OFF	Central Venous Catheter Tray	Class 2	21 CFR 870.1140
OFG	Ct Biopsy Tray	Class 2	21 CFR 870.4075
OFH	Digital Angiography Tray	Class 2	21 CFR 870.1650
OFI	Laser Blood Flow Kit	Class 2	21 CFR 870.2120
OFJ	Lead Introducer Kit	Class 2	21 CFR 870.1340
OFK	Percutaneous Atrial Catheter Kit	Class 2	21 CFR 870.1250
OFL	Percutaneous Sheath Introducer Kit	Class 2	21 CFR 870.1340
OFM	Phlebotomy Blood Collection Kit	Class 2	21 CFR 870.2750
OFN	Winged Intravenous Catheterization Kit	Class 2	21 CFR 870.1200
OGZ	Catheter, Intravascular, Plaque Morphology Evaluation	Class 2	21 CFR 870.1200	9
OJQ	Cardiac Allograft Gene Expression Profiling Test System	Class 2	21 CFR 862.1163	2
OKR	Ventricular Bypass (Assist) Device	Class 3	21 CFR 870.3545
OLK	Pulse Oximeter For Over-The-Counter Use	Class 2	21 CFR 870.2700	2
OMH	Pericardial Patch To Facilitate Revision Surgeries	Class 2	21 CFR 870.3470	1
OMR	Vessel Guard Or Cover	Class 2	21 CFR 870.3470	10
OMV	Ultrasonic Body Composition Analyzer	Class 2	21 CFR 870.2770	1
OMZ	Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplast	Class 2	21 CFR 870.1250	5
ORD	Optical Coherence Tomography, Intravascular Catheter	Class 2	21 CFR 870.1200
OTD	Endovascular Suturing System	Class 2	21 CFR 870.3460	7
OVJ	Pulse Generator, External Pacemaker, Dual Chamber	Class 2	21 CFR 870.3600
OWQ	Reprocessed Intravascular Ultrasound Catheter	Class 2	21 CFR 870.1200	31
OZT	Balloon Aortic Valvuloplasty	Class 2	21 CFR 870.1255	22
PAL	Pulmonic Replacement Heart Valve	Class F	21 CFR 870.3925
PAW	Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Cho	Class 2	21 CFR 870.3470	3
PCK	Pediatric Ventricular Assist Device	Class F	21 CFR 870.3545
PDU	Catheter For Crossing Total Occlusions	Class 2	21 CFR 870.1250	58
PFA	Non-Invasive Central Venous Manometer	Class 2	21 CFR 870.1140	2
PFY	Low Patient Acuity Monitoring System	Class 2	21 CFR 870.2300
PGJ	Oximeter, Wellness	Class 2	21 CFR 870.2700
PJA	Coronary Vascular Physiologic Simulation Software	Class 2	21 CFR 870.1415	9
PJB	Catheter Remote Control System	Class 2	21 CFR 870.5700	4
PLA	Esophageal Thermal Regulation And Gastric Suctioning Device	Class 2	21 CFR 870.5910	9
PLB	Multivariate Vital Signs Index	Class 2	21 CFR 870.2300	8
PMJ	Cpr Aid Feedback Device (No Software)	Class 2	21 CFR 870.5210
PMK	Cpr Aid Device Without Feedback	Class 1	21 CFR 870.5210	2
PNE	Reprocessed Catheter Introducer	Class 2	21 CFR 870.1340	7
PNJ	Leadless Pacemaker	Class 3	21 CFR 870.3610
PNO	Catheter, Percutaneous, Cutting/Scoring	Class 2	21 CFR 870.1250	45
PNQ	Apical Closure Device	Class 2	21 CFR 870.4510	1
PNS	Short-Term Intravascular Filter Catheter	Class 2	21 CFR 870.3375	1
PPN	Percutaneous Catheter, Ultrasound	Class 2	21 CFR 870.1250	14
PPS	Sleeve, Head And Neck, Compressible	Class 2	21 CFR 870.5800	1
PPW	Adjunctive Cardiovascular Status Indicator	Class 2	21 CFR 870.2200	8
PQK	Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hem	Class 2	21 CFR 870.1252	7
PSQ	Intracardiac Patch Or Pledget, Biologically Derived	Class 2	21 CFR 870.3470	11
PST	Aortic Annuloplasty Ring	Class 2	21 CFR 870.3800	2
PTL	Wire, Guide, Catheter, Exempt	Class 2	21 CFR 870.1330
PTM	Syringe, Balloon Inflation, Exempt	Class 2	21 CFR 870.1650
PTN	Reservoir, Blood, Cardiopulmonary Bypass, Exempt	Class 2	21 CFR 870.4400
PUH	Analyzer, Body Composition, Exempt	Class 2	21 CFR 870.2770
PUM	Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Pro	Class 2	21 CFR 870.1251	2
PYX	Temporary Non-Roller Type Right Heart Support Blood Pump	Class 3	21 CFR 870.4360
PZS	Dual Lumen Ecmo Cannula	Class 2	21 CFR 870.4100	4
QAB	Pacing System Analyzer	Class 2	21 CFR 870.3605
QAF	Impedance Plethysmograph, Cranial	Class 2	21 CFR 870.2770	3
QAQ	Adjunctive Predictive Cardiovascular Indicator	Class 2	21 CFR 870.2210	5
QBE	Cranial Sound Monitor	Class 2	21 CFR 870.1875	1
QDA	Electrocardiograph Software For Over-The-Counter Use	Class 2	21 CFR 870.2345	9
QDB	Photoplethysmograph Analysis Software For Over-The-Counter Use	Class 2	21 CFR 870.2790	5
QEK	Angiographic Coronary Vascular Physiologic Simulation Software	Class 2	21 CFR 870.1415	2
QEM	Cerebral Oximeter	Class 2	21 CFR 870.2700	1
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Class 2	21 CFR 870.5150	143
QEX	Coronary Mechanical Thrombectomy With Aspiration	Class 2	21 CFR 870.5150	3
QEY	Mechanical Thrombolysis Catheter	Class 2	21 CFR 870.5150	71
QEZ	Aspiration Thrombectomy Catheter	Class 2	21 CFR 870.5150	94
QFJ	Intravascular Bleed Monitor	Class 2	21 CFR 870.1345	2
QHW	Single Lumen Ecmo Cannula	Class 2	21 CFR 870.4100	3
QJB	Adjunct Monitor, Protein Calorie Malnutrition	Class 2	21 CFR 870.2770	2
QJH	Reverse Central Venous Recanalization System	Class 2	21 CFR 870.1342	2
QJP	Catheter, Percutaneous, Neurovasculature	Class 2	21 CFR 870.1250	98
QJZ	Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Fail	Class 2	21 CFR 870.4100	4
QLZ	Septostomy Catheter, Reprocessed	Class 2	21 CFR 870.5175	2
QME	Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rat	Class 2	21 CFR 870.2785	13
QMS	Adjunctive Open Loop Fluid Therapy Recommender	Class 2	21 CFR 870.5600	2
QMW	Coronary Artery Disease Risk Indicator From Acoustic Heart Signals	Class 2	21 CFR 870.1420	1
QNL	Medium-Term Adjunctive Predictive Cardiovascular Indicator	Class 2	21 CFR 870.2210	5
QNR	Blood Pump For Ecmo, Long-Term (> 6 Hours) Use	Class 2	21 CFR 870.4100	8
QNV	Adjunctive Hemodynamic Indicator With Decision Point	Class 2	21 CFR 870.2220	3
QOH	Extracorporeal System For Carbon Dioxide Removal	Class 2	21 CFR 870.4150	1
QOK	Hardware And Software For Optical Camera-Based Measurement Of Heart Ra	Class 2	21 CFR 870.2786	1
QQI	Interventional Cardiovascular Implant Simulation Software Device	Class 2	21 CFR 870.1405	4
QRJ	Laser-Powered Inferior Vena Cava Filter Retrieval Catheter	Class 2	21 CFR 870.5125	1
QTF	Reprocessed Atherectomy Catheter	Class 2	21 CFR 870.4875	1
QUO	Adjunctive Heart Failure Status Indicator	Class 2	21 CFR 870.2200	4
QVQ	Extravascular Support For An Arteriovenous Fistula For Vascular Access	Class 2	21 CFR 870.4600	2
QWA	Cardiovascular Delivery Catheter System Positioning And Stabilization	Class 1	21 CFR 870.3955
QWF	Tubing, Long Term Support Greater Than 6 Hours	Class 2	21 CFR 870.4100	1
QXO	Cardiovascular Machine Learning-Based Notification Software	Class 2	21 CFR 870.2380	2
QXU	Esophageal Protection Device For Use In Percutaneous Cardiac Catheter	Class 2	21 CFR 870.5710	2
QXV	Temperature Regulation Device For Esophageal Protection During Cardiac	Class 2	21 CFR 870.5720	1
QXX	Coronary Artery Disease Machine Learning-Based Notification Software	Class 2	21 CFR 870.2380	1
QXY	Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notificatio	Class 2	21 CFR 870.1135	1
QXZ	Adjunctive Epicardial Vascular Physiologic Status Indicator	Class 2	21 CFR 870.2200	1
QYE	Reduced Ejection Fraction Machine Learning-Based Notification Software	Class 2	21 CFR 870.2380	5
QYF	Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes	Class 2	21 CFR 870.1130
QYU	Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter U	Class 2	21 CFR 870.2705	2
QYW	Hospital Cardiac Telemetry	Class 2	21 CFR 870.1025	2
QYX	Outpatient Cardiac Telemetry	Class 2	21 CFR 870.1025	21
QZU	Temporary Embolization Assist Device, Peripheral	Class 2	21 CFR 870.3325	1
SAR	Adjunctive Hemodynamic Indicator With Decision Point For Military Use	Class 2	21 CFR 870.2220	1
SAT	Pulmonary Hypertension Machine Learning-Based Notification Software	Class 2	21 CFR 870.2380	3
SBK	Artificial Chordae Tendineae Surgical Replacement System	Class 2	21 CFR 870.3490	1
SBQ	Atrial Fibrillation Risk Prediction Machine Learning-Based Notificatio	Class 2	21 CFR 870.2380	1
SCZ	Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Co	Class 2	21 CFR 870.1254	1
SDJ	Adjunctive Cardiac Amyloidosis Status Indicator	Class 2	21 CFR 870.2200	3
SDY	Loss Of Pulse Notification Software	Class 2	21 CFR 870.2790	1
SEU	Peripheral Temporary And Retrievable Stent System	Class 2	21 CFR 870.5110	1
SFR	Hypertension Machine Learning-Based Notification Software	Class 2	21 CFR 870.2380	1
SGO	Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets	Class 2	21 CFR 870.1254	1
SHP	Cardiac Amyloidosis Machine Learning-Based Notification Software	Class 2	21 CFR 870.2380	1
SHR	Device For Open Surgical Explant Of Endovascular Prostheses	Class 2	21 CFR 870.4520	1
SIF	Software Device System For Estimation Of Cardiac Pressures	Class 2	21 CFR 870.1150	1
SII	Aortic Stenosis Machine Learning-Based Notification Software	Class 2	21 CFR 870.2380
SIJ	Valvular Regurgitation Machine Learning-Based Notification Software	Class 2	21 CFR 870.2380
SIK	Cardiac Hypertrophy Machine Learning-Based Notification Software	Class 2	21 CFR 870.2380
SIU	Predictive Indicator For Long-Term Cardiovascular Outcomes	Class 2	21 CFR 870.2215	1