Part 870 Subpart B—Cardiovascular Diagnostic Devices
FDA submissions for Part 870 Subpart B—Cardiovascular Diagnostic Devices in the Cardiovascular (CV) review panel, including product codes and regulations.
Section range: §§ 870.1025–870.1915
CFR Part: 870
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | 870.1025 | 2 | 398 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 870.1025 | 2 | 421 |
| MLD | Monitor, St Segment With Alarm | 870.1025 | 2 | 14 |
| MXD | Recorder, Event, Implantable Cardiac, (With Arrhythmia Detection) | 870.1025 | 2 | 32 |
| QYW | Hospital Cardiac Telemetry | 870.1025 | 2 | 2 |
| QYX | Outpatient Cardiac Telemetry | 870.1025 | 2 | 20 |
| DSJ | Alarm, Blood-Pressure | 870.1100 | 2 | 6 |
| DSK | Computer, Blood-Pressure | 870.1110 | 2 | 77 |
| DXQ | Blood Pressure Cuff | 870.1120 | 2 | 197 |
| NPP | Reprocessed Blood Pressure Cuff | 870.1120 | 2 | 1 |
| OED | Antimicrobial Blood Pressure Cuff | 870.1120 | 2 | 2 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 870.1130 | 2 | 1207 |
| QYF | Neonatal Icu Continuous Non-Invasive Blood Pressure Monitor (Includes Alarms) | 870.1130 | 2 | 0 |
| QXY | Oscillometric-Based, Over-The-Counter, Atrial Fibrillation Notification Feature | 870.1135 | 2 | 1 |
| KRK | Manometer, Blood-Pressure, Venous | 870.1140 | 2 | 9 |
| OFE | Central Venous Blood Pressure Kit | 870.1140 | 2 | 0 |
| OFF | Central Venous Catheter Tray | 870.1140 | 2 | 0 |
| PFA | Non-Invasive Central Venous Manometer | 870.1140 | 2 | 2 |
| DQO | Catheter, Intravascular, Diagnostic | 870.1200 | 2 | 499 |
| NLI | Catheter, Angiography, Reprocessed | 870.1200 | 2 | 1 |
| NUI | Ultrasound, Infusion, System | 870.1200 | 2 | 4 |
| OBI | Catheter, Pressure Monitoring, Cardiac | 870.1200 | 2 | 1 |
| OBJ | Catheter, Ultrasound, Intravascular | 870.1200 | 2 | 78 |
| OES | Cardiac Catheterization Kit | 870.1200 | 2 | 0 |
| OEZ | Cardiovascular Procedure Kit | 870.1200 | 2 | 0 |
| OFN | Winged Intravenous Catheterization Kit | 870.1200 | 2 | 0 |
| OGZ | Catheter, Intravascular, Plaque Morphology Evaluation | 870.1200 | 2 | 9 |
| ORD | Optical Coherence Tomography, Intravascular Catheter | 870.1200 | 2 | 0 |
| OWQ | Reprocessed Intravascular Ultrasound Catheter | 870.1200 | 2 | 30 |
| KRA | Catheter, Continuous Flush | 870.1210 | 2 | 173 |
| NPG | Catheter, Infusion, Syringe | 870.1210 | 2 | 1 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 870.1220 | 2 | 186 |
| MTD | Catheter, Intracardiac Mapping, High-Density Array | 870.1220 | 2 | 33 |
| NLG | Catheter, Intracardiac Mapping, High-Density, Reprocessed | 870.1220 | 2 | 3 |
| NLH | Catheter, Recording, Electrode, Reprocessed | 870.1220 | 2 | 70 |
| DQE | Catheter, Oximeter, Fiber-Optic | 870.1230 | 2 | 19 |
| NMB | Catheter, Oximeter, Fiber Optic, Reprocessed | 870.1230 | 2 | 0 |
| DYG | Catheter, Flow Directed | 870.1240 | 2 | 99 |
| DQY | Catheter, Percutaneous | 870.1250 | 2 | 887 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 870.1250 | 2 | 402 |
| NFA | Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection | 870.1250 | 2 | 22 |
| NMM | Catheter, Angioplasty, Peripheral, Transluminal, Reprocessed | 870.1250 | 2 | 0 |
| NRY | Catheter, Thrombus Retriever | 870.1250 | 2 | 106 |
| NTE | Temporary Carotid Catheter For Embolic Capture | 870.1250 | 2 | 36 |
| NVM | Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon | 870.1250 | 2 | 5 |
| OFK | Percutaneous Atrial Catheter Kit | 870.1250 | 2 | 0 |
| OMZ | Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter | 870.1250 | 2 | 5 |
| PDU | Catheter For Crossing Total Occlusions | 870.1250 | 2 | 57 |
| PNO | Catheter, Percutaneous, Cutting/Scoring | 870.1250 | 2 | 45 |
| PPN | Percutaneous Catheter, Ultrasound | 870.1250 | 2 | 12 |
| QJP | Catheter, Percutaneous, Neurovasculature | 870.1250 | 2 | 88 |
| PUM | Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures | 870.1251 | 2 | 2 |
| PQK | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access | 870.1252 | 2 | 7 |
| SCZ | Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures | 870.1254 | 2 | 1 |
| SGO | Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures | 870.1254 | 2 | 1 |
| OZT | Balloon Aortic Valvuloplasty | 870.1255 | 2 | 21 |
| DXW | System, Phonocatheter, Intracavitary | 870.1270 | 2 | 5 |
| DRA | Catheter, Steerable | 870.1280 | 2 | 41 |
| NKS | Catheter, Steerable, Reprocessed | 870.1280 | 2 | 0 |
| DXX | System, Catheter Control, Steerable | 870.1290 | 2 | 33 |
| NDQ | System, Catheter Or Guidewire, Steerable (Magnetic) | 870.1290 | 2 | 2 |
| NKR | System, Catheter Control, Reprocessed | 870.1290 | 2 | 0 |
| DQR | Cannula, Catheter | 870.1300 | 2 | 25 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 870.1310 | 2 | 104 |
| DQX | Wire, Guide, Catheter | 870.1330 | 2 | 763 |
| MOF | Guide, Wire, Catheter, Neurovasculature | 870.1330 | 2 | 39 |
| NKQ | Guidewire, Catheter, Reprocessed | 870.1330 | 2 | 0 |
| OFB | Catheter Guide Wire Kit | 870.1330 | 2 | 0 |
| PTL | Wire, Guide, Catheter, Exempt | 870.1330 | 2 | 0 |
| DYB | Introducer, Catheter | 870.1340 | 2 | 699 |
| OEX | Cardiovascular Catheter Sheath Introducer Kit | 870.1340 | 2 | 0 |
| OFC | Catheter Introducer Kit | 870.1340 | 2 | 1 |
| OFD | Catheter Introducer Kit | 870.1340 | 2 | 0 |
| OFJ | Lead Introducer Kit | 870.1340 | 2 | 0 |
| OFL | Percutaneous Sheath Introducer Kit | 870.1340 | 2 | 0 |
| PNE | Reprocessed Catheter Introducer | 870.1340 | 2 | 7 |
| QJH | Reverse Central Venous Recanalization System | 870.1342 | 2 | 2 |
| QFJ | Intravascular Bleed Monitor | 870.1345 | 2 | 2 |
| DQP | Kit, Balloon Repair, Catheter | 870.1350 | 3 | 0 |
| DQG | Microsphere, Trace | 870.1360 | 3 | 0 |
| DQT | Occluder, Catheter Tip | 870.1370 | 2 | 12 |
| DRB | Stylet, Catheter | 870.1380 | 2 | 28 |
| DRC | Trocar | 870.1390 | 2 | 51 |
| NMK | Trocar, Reprocessed | 870.1390 | 2 | 1 |
| QQI | Interventional Cardiovascular Implant Simulation Software Device | 870.1405 | 2 | 4 |
| PJA | Coronary Vascular Physiologic Simulation Software | 870.1415 | 2 | 9 |
| QEK | Angiographic Coronary Vascular Physiologic Simulation Software | 870.1415 | 2 | 2 |
| QMW | Coronary Artery Disease Risk Indicator From Acoustic Heart Signals | 870.1420 | 2 | 1 |
| DQK | Computer, Diagnostic, Programmable | 870.1425 | 2 | 426 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 870.1435 | 2 | 177 |
| DXM | Densitometer | 870.1450 | 2 | 2 |
| DXT | Injector And Syringe, Angiographic | 870.1650 | 2 | 207 |
| IZQ | Injector, Contrast Medium, Automatic | 870.1650 | 2 | 22 |
| MAV | Syringe, Balloon Inflation | 870.1650 | 2 | 57 |
| NKP | Injector, Contrast Medium, Automatic, Reprocessed | 870.1650 | 2 | 0 |
| NKT | Injector And Syringe, Angiographic, Reprocessed | 870.1650 | 2 | 0 |
| NKU | Injector And Syringe, Angiographic, Balloon Inflation, Reprocessed | 870.1650 | 2 | 1 |
| OEQ | Angiography/Angioplasty Kit | 870.1650 | 2 | 0 |
| OER | Angioscopic Valvulotome Kit | 870.1650 | 2 | 0 |
| OFH | Digital Angiography Tray | 870.1650 | 2 | 0 |
| PTM | Syringe, Balloon Inflation, Exempt | 870.1650 | 2 | 0 |
| DXL | Injector, Indicator | 870.1660 | 2 | 3 |
| DQF | Actuator, Syringe, Injector Type | 870.1670 | 2 | 3 |
| NKW | Actuator, Syringe, For Injector, Reprocessed | 870.1670 | 2 | 0 |
| JOQ | Generator, Pulse, Pacemaker, External Programmable (For Electrophysiological Studies Only) | 870.1750 | 2 | 19 |
| DQI | Withdrawal/Infusion Pump | 870.1800 | 2 | 9 |
| DQD | Stethoscope, Electronic | 870.1875 | 2 | 153 |
| LDE | Stethoscope, Manual | 870.1875 | 1 | 28 |
| OCR | Lung Sound Monitor | 870.1875 | 2 | 3 |
| QBE | Cranial Sound Monitor | 870.1875 | 2 | 1 |
| KRB | Probe, Thermodilution | 870.1915 | 2 | 37 |
