| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| NMF | Clamp, Vascular, Reprocessed | 第 2 类 | 21 CFR 870.4450 | 3 |
| NMK | Trocar, Reprocessed | 第 2 类 | 21 CFR 870.1390 | 1 |
| NMM | Catheter, Angioplasty, Peripheral, Transluminal, Reprocessed | 第 2 类 | 21 CFR 870.1250 | |
| NPG | Catheter, Infusion, Syringe | 第 2 类 | 21 CFR 870.1210 | 1 |
| NPP | Reprocessed Blood Pressure Cuff | 第 2 类 | 21 CFR 870.1120 | 1 |
| NQG | Stabilizer, Heart, Non-Compression, Reprocessed | 第 1 类 | 21 CFR 870.4500 | 3 |
| NQH | Sensor, Pressure, Aneurysm, Implantable | 第 2 类 | 21 CFR 870.2855 | 5 |
| NRY | Catheter, Thrombus Retriever | 第 2 类 | 21 CFR 870.1250 | 114 |
| NSA | Over-The-Counter Automated External Defibrillator | 第 3 类 | 21 CFR 870.5310 | 1 |
| NTE | Temporary Carotid Catheter For Embolic Capture | 第 2 类 | 21 CFR 870.1250 | 36 |
| NUI | Ultrasound, Infusion, System | 第 2 类 | 21 CFR 870.1200 | 4 |
| NVM | Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon | 第 2 类 | 21 CFR 870.1250 | 5 |
| NZE | Hyperthermia Monitor | 第 2 类 | 21 CFR 870.5900 | 6 |
| OAC | Plethysmograph, Air Displacement For Body Composition Analysis | 第 2 类 | 21 CFR 870.2770 | 3 |
| OBH | Monitor, Extracellular Fluid, Lymphedema, Extremity | 第 2 类 | 21 CFR 870.2770 | 10 |
| OBI | Catheter, Pressure Monitoring, Cardiac | 第 2 类 | 21 CFR 870.1200 | 1 |
| OBJ | Catheter, Ultrasound, Intravascular | 第 2 类 | 21 CFR 870.1200 | 79 |
| OCH | Oximeter, Infrared, Sporting, Aviation | 第 2 类 | 21 CFR 870.2700 | |
| OCR | Lung Sound Monitor | 第 2 类 | 21 CFR 870.1875 | 3 |
| OED | Antimicrobial Blood Pressure Cuff | 第 2 类 | 21 CFR 870.1120 | 2 |
| OEQ | Angiography/Angioplasty Kit | 第 2 类 | 21 CFR 870.1650 | |
| OER | Angioscopic Valvulotome Kit | 第 2 类 | 21 CFR 870.1650 | |
| OES | Cardiac Catheterization Kit | 第 2 类 | 21 CFR 870.1200 | |
| OET | Cardioplegia Solution Administration Kit | 第 2 类 | 21 CFR 870.4240 | |
| OEU | Cardiopulmonary Bypass Catheter Kit | 第 2 类 | 21 CFR 870.4210 | |
| OEX | Cardiovascular Catheter Sheath Introducer Kit | 第 2 类 | 21 CFR 870.1340 | |
| OEZ | Cardiovascular Procedure Kit | 第 2 类 | 21 CFR 870.1200 | |
| OFA | Cardiovascular Surgical Instruments Tray | 第 1 类 | 21 CFR 870.4500 | |
| OFB | Catheter Guide Wire Kit | 第 2 类 | 21 CFR 870.1330 | |
| OFC | Catheter Introducer Kit | 第 2 类 | 21 CFR 870.1340 | 1 |
| OFD | Catheter Introducer Kit | 第 2 类 | 21 CFR 870.1340 | |
| OFE | Central Venous Blood Pressure Kit | 第 2 类 | 21 CFR 870.1140 | |
| OFF | Central Venous Catheter Tray | 第 2 类 | 21 CFR 870.1140 | |
| OFG | Ct Biopsy Tray | 第 2 类 | 21 CFR 870.4075 | |
| OFH | Digital Angiography Tray | 第 2 类 | 21 CFR 870.1650 | |
| OFI | Laser Blood Flow Kit | 第 2 类 | 21 CFR 870.2120 | |
| OFJ | Lead Introducer Kit | 第 2 类 | 21 CFR 870.1340 | |
| OFK | Percutaneous Atrial Catheter Kit | 第 2 类 | 21 CFR 870.1250 | |
| OFL | Percutaneous Sheath Introducer Kit | 第 2 类 | 21 CFR 870.1340 | |
| OFM | Phlebotomy Blood Collection Kit | 第 2 类 | 21 CFR 870.2750 | |
| OFN | Winged Intravenous Catheterization Kit | 第 2 类 | 21 CFR 870.1200 | |
| OGZ | Catheter, Intravascular, Plaque Morphology Evaluation | 第 2 类 | 21 CFR 870.1200 | 9 |
| OJQ | Cardiac Allograft Gene Expression Profiling Test System | 第 2 类 | 21 CFR 862.1163 | 2 |
| OKR | Ventricular Bypass (Assist) Device | 第 3 类 | 21 CFR 870.3545 | |
| OLK | Pulse Oximeter For Over-The-Counter Use | 第 2 类 | 21 CFR 870.2700 | 2 |
| OMH | Pericardial Patch To Facilitate Revision Surgeries | 第 2 类 | 21 CFR 870.3470 | 1 |
| OMR | Vessel Guard Or Cover | 第 2 类 | 21 CFR 870.3470 | 10 |
| OMV | Ultrasonic Body Composition Analyzer | 第 2 类 | 21 CFR 870.2770 | 1 |
| OMZ | Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplast | 第 2 类 | 21 CFR 870.1250 | 5 |
| ORD | Optical Coherence Tomography, Intravascular Catheter | 第 2 类 | 21 CFR 870.1200 | |
| OTD | Endovascular Suturing System | 第 2 类 | 21 CFR 870.3460 | 7 |
| OVJ | Pulse Generator, External Pacemaker, Dual Chamber | 第 2 类 | 21 CFR 870.3600 | |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | 第 2 类 | 21 CFR 870.1200 | 31 |
| OZT | Balloon Aortic Valvuloplasty | 第 2 类 | 21 CFR 870.1255 | 22 |
| PAL | Pulmonic Replacement Heart Valve | 第 F 类 | 21 CFR 870.3925 | |
| PAW | Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Cho | 第 2 类 | 21 CFR 870.3470 | 3 |
| PCK | Pediatric Ventricular Assist Device | 第 F 类 | 21 CFR 870.3545 | |
| PDU | Catheter For Crossing Total Occlusions | 第 2 类 | 21 CFR 870.1250 | 58 |
| PFA | Non-Invasive Central Venous Manometer | 第 2 类 | 21 CFR 870.1140 | 2 |
| PFY | Low Patient Acuity Monitoring System | 第 2 类 | 21 CFR 870.2300 | |
| PGJ | Oximeter, Wellness | 第 2 类 | 21 CFR 870.2700 | |
| PJA | Coronary Vascular Physiologic Simulation Software | 第 2 类 | 21 CFR 870.1415 | 9 |
| PJB | Catheter Remote Control System | 第 2 类 | 21 CFR 870.5700 | 4 |
| PLA | Esophageal Thermal Regulation And Gastric Suctioning Device | 第 2 类 | 21 CFR 870.5910 | 9 |
| PLB | Multivariate Vital Signs Index | 第 2 类 | 21 CFR 870.2300 | 8 |
| PMJ | Cpr Aid Feedback Device (No Software) | 第 2 类 | 21 CFR 870.5210 | |
| PMK | Cpr Aid Device Without Feedback | 第 1 类 | 21 CFR 870.5210 | 2 |
| PNE | Reprocessed Catheter Introducer | 第 2 类 | 21 CFR 870.1340 | 7 |
| PNJ | Leadless Pacemaker | 第 3 类 | 21 CFR 870.3610 | |
| PNO | Catheter, Percutaneous, Cutting/Scoring | 第 2 类 | 21 CFR 870.1250 | 45 |
| PNQ | Apical Closure Device | 第 2 类 | 21 CFR 870.4510 | 1 |
| PNS | Short-Term Intravascular Filter Catheter | 第 2 类 | 21 CFR 870.3375 | 1 |
| PPN | Percutaneous Catheter, Ultrasound | 第 2 类 | 21 CFR 870.1250 | 14 |
| PPS | Sleeve, Head And Neck, Compressible | 第 2 类 | 21 CFR 870.5800 | 1 |
| PPW | Adjunctive Cardiovascular Status Indicator | 第 2 类 | 21 CFR 870.2200 | 8 |
| PQK | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hem | 第 2 类 | 21 CFR 870.1252 | 7 |
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived | 第 2 类 | 21 CFR 870.3470 | 11 |
| PST | Aortic Annuloplasty Ring | 第 2 类 | 21 CFR 870.3800 | 2 |
| PTL | Wire, Guide, Catheter, Exempt | 第 2 类 | 21 CFR 870.1330 | |
| PTM | Syringe, Balloon Inflation, Exempt | 第 2 类 | 21 CFR 870.1650 | |
| PTN | Reservoir, Blood, Cardiopulmonary Bypass, Exempt | 第 2 类 | 21 CFR 870.4400 | |
| PUH | Analyzer, Body Composition, Exempt | 第 2 类 | 21 CFR 870.2770 | |
| PUM | Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Pro | 第 2 类 | 21 CFR 870.1251 | 2 |
| PYX | Temporary Non-Roller Type Right Heart Support Blood Pump | 第 3 类 | 21 CFR 870.4360 | |
| PZS | Dual Lumen Ecmo Cannula | 第 2 类 | 21 CFR 870.4100 | 4 |
| QAB | Pacing System Analyzer | 第 2 类 | 21 CFR 870.3605 | |
| QAF | Impedance Plethysmograph, Cranial | 第 2 类 | 21 CFR 870.2770 | 3 |
| QAQ | Adjunctive Predictive Cardiovascular Indicator | 第 2 类 | 21 CFR 870.2210 | 5 |
| QBE | Cranial Sound Monitor | 第 2 类 | 21 CFR 870.1875 | 1 |
| QDA | Electrocardiograph Software For Over-The-Counter Use | 第 2 类 | 21 CFR 870.2345 | 9 |
| QDB | Photoplethysmograph Analysis Software For Over-The-Counter Use | 第 2 类 | 21 CFR 870.2790 | 5 |
| QEK | Angiographic Coronary Vascular Physiologic Simulation Software | 第 2 类 | 21 CFR 870.1415 | 2 |
| QEM | Cerebral Oximeter | 第 2 类 | 21 CFR 870.2700 | 1 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 第 2 类 | 21 CFR 870.5150 | 143 |
| QEX | Coronary Mechanical Thrombectomy With Aspiration | 第 2 类 | 21 CFR 870.5150 | 3 |
| QEY | Mechanical Thrombolysis Catheter | 第 2 类 | 21 CFR 870.5150 | 71 |
| QEZ | Aspiration Thrombectomy Catheter | 第 2 类 | 21 CFR 870.5150 | 94 |
| QFJ | Intravascular Bleed Monitor | 第 2 类 | 21 CFR 870.1345 | 2 |
| QHW | Single Lumen Ecmo Cannula | 第 2 类 | 21 CFR 870.4100 | 3 |
| QJB | Adjunct Monitor, Protein Calorie Malnutrition | 第 2 类 | 21 CFR 870.2770 | 2 |
| QJH | Reverse Central Venous Recanalization System | 第 2 类 | 21 CFR 870.1342 | 2 |
| QJP | Catheter, Percutaneous, Neurovasculature | 第 2 类 | 21 CFR 870.1250 | 98 |
| QJZ | Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Fail | 第 2 类 | 21 CFR 870.4100 | 4 |
| QLZ | Septostomy Catheter, Reprocessed | 第 2 类 | 21 CFR 870.5175 | 2 |
| QME | Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rat | 第 2 类 | 21 CFR 870.2785 | 13 |
| QMS | Adjunctive Open Loop Fluid Therapy Recommender | 第 2 类 | 21 CFR 870.5600 | 2 |
| QMW | Coronary Artery Disease Risk Indicator From Acoustic Heart Signals | 第 2 类 | 21 CFR 870.1420 | 1 |
| QNL | Medium-Term Adjunctive Predictive Cardiovascular Indicator | 第 2 类 | 21 CFR 870.2210 | 5 |
| QNR | Blood Pump For Ecmo, Long-Term (> 6 Hours) Use | 第 2 类 | 21 CFR 870.4100 | 8 |
| QNV | Adjunctive Hemodynamic Indicator With Decision Point | 第 2 类 | 21 CFR 870.2220 | 3 |
| QOH | Extracorporeal System For Carbon Dioxide Removal | 第 2 类 | 21 CFR 870.4150 | 1 |
| QOK | Hardware And Software For Optical Camera-Based Measurement Of Heart Ra | 第 2 类 | 21 CFR 870.2786 | 1 |
| QQI | Interventional Cardiovascular Implant Simulation Software Device | 第 2 类 | 21 CFR 870.1405 | 4 |
| QRJ | Laser-Powered Inferior Vena Cava Filter Retrieval Catheter | 第 2 类 | 21 CFR 870.5125 | 1 |
| QTF | Reprocessed Atherectomy Catheter | 第 2 类 | 21 CFR 870.4875 | 1 |
| QUO | Adjunctive Heart Failure Status Indicator | 第 2 类 | 21 CFR 870.2200 | 4 |
| QVQ | Extravascular Support For An Arteriovenous Fistula For Vascular Access | 第 2 类 | 21 CFR 870.4600 | 2 |
| QWA | Cardiovascular Delivery Catheter System Positioning And Stabilization | 第 1 类 | 21 CFR 870.3955 | |
| QWF | Tubing, Long Term Support Greater Than 6 Hours | 第 2 类 | 21 CFR 870.4100 | 1 |
| QXO | Cardiovascular Machine Learning-Based Notification Software | 第 2 类 | 21 CFR 870.2380 | 2 |
| QXU | Esophageal Protection Device For Use In Percutaneous Cardiac Catheter | 第 2 类 | 21 CFR 870.5710 | 2 |
| QXV | Temperature Regulation Device For Esophageal Protection During Cardiac | 第 2 类 | 21 CFR 870.5720 | 1 |
| QXX | Coronary Artery Disease Machine Learning-Based Notification Software | 第 2 类 | 21 CFR 870.2380 | 1 |
| QXY | Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notificatio | 第 2 类 | 21 CFR 870.1135 | 1 |
| QXZ | Adjunctive Epicardial Vascular Physiologic Status Indicator | 第 2 类 | 21 CFR 870.2200 | 1 |
| QYE | Reduced Ejection Fraction Machine Learning-Based Notification Software | 第 2 类 | 21 CFR 870.2380 | 5 |
| QYF | Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes | 第 2 类 | 21 CFR 870.1130 | |
| QYU | Infant Pulse Rate And Oxygen Saturation Monitor For Over-The-Counter U | 第 2 类 | 21 CFR 870.2705 | 2 |
| QYW | Hospital Cardiac Telemetry | 第 2 类 | 21 CFR 870.1025 | 2 |
| QYX | Outpatient Cardiac Telemetry | 第 2 类 | 21 CFR 870.1025 | 21 |
| QZU | Temporary Embolization Assist Device, Peripheral | 第 2 类 | 21 CFR 870.3325 | 1 |
| SAR | Adjunctive Hemodynamic Indicator With Decision Point For Military Use | 第 2 类 | 21 CFR 870.2220 | 1 |
| SAT | Pulmonary Hypertension Machine Learning-Based Notification Software | 第 2 类 | 21 CFR 870.2380 | 3 |
| SBK | Artificial Chordae Tendineae Surgical Replacement System | 第 2 类 | 21 CFR 870.3490 | 1 |
| SBQ | Atrial Fibrillation Risk Prediction Machine Learning-Based Notificatio | 第 2 类 | 21 CFR 870.2380 | 1 |
| SCZ | Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Co | 第 2 类 | 21 CFR 870.1254 | 1 |
| SDJ | Adjunctive Cardiac Amyloidosis Status Indicator | 第 2 类 | 21 CFR 870.2200 | 3 |
| SDY | Loss Of Pulse Notification Software | 第 2 类 | 21 CFR 870.2790 | 1 |
| SEU | Peripheral Temporary And Retrievable Stent System | 第 2 类 | 21 CFR 870.5110 | 1 |
| SFR | Hypertension Machine Learning-Based Notification Software | 第 2 类 | 21 CFR 870.2380 | 1 |
| SGO | Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets | 第 2 类 | 21 CFR 870.1254 | 1 |
| SHP | Cardiac Amyloidosis Machine Learning-Based Notification Software | 第 2 类 | 21 CFR 870.2380 | 1 |
| SHR | Device For Open Surgical Explant Of Endovascular Prostheses | 第 2 类 | 21 CFR 870.4520 | 1 |
| SIF | Software Device System For Estimation Of Cardiac Pressures | 第 2 类 | 21 CFR 870.1150 | 1 |
| SII | Aortic Stenosis Machine Learning-Based Notification Software | 第 2 类 | 21 CFR 870.2380 | |
| SIJ | Valvular Regurgitation Machine Learning-Based Notification Software | 第 2 类 | 21 CFR 870.2380 | |
| SIK | Cardiac Hypertrophy Machine Learning-Based Notification Software | 第 2 类 | 21 CFR 870.2380 | |
| SIU | Predictive Indicator For Long-Term Cardiovascular Outcomes | 第 2 类 | 21 CFR 870.2215 | 1 |