Part 870 Subpart F—Cardiovascular Therapeutic Devices
FDA submissions for Part 870 Subpart F—Cardiovascular Therapeutic Devices in the Cardiovascular (CV) review panel, including product codes and regulations.
Section range: §§ 870.5050–870.5925
CFR Part: 870
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| DWM | Apparatus, Suction, Patient Care | 870.5050 | 2 | 19 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 870.5100 | 2 | 106 |
| SEU | Peripheral Temporary And Retrievable Stent System | 870.5110 | 2 | 1 |
| QRJ | Laser-Powered Inferior Vena Cava Filter Retrieval Catheter | 870.5125 | 2 | 1 |
| DXE | Catheter, Embolectomy | 870.5150 | 2 | 74 |
| MMX | Device, Percutaneous Retrieval | 870.5150 | 2 | 32 |
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | 870.5150 | 2 | 141 |
| QEX | Coronary Mechanical Thrombectomy With Aspiration | 870.5150 | 2 | 3 |
| QEY | Mechanical Thrombolysis Catheter | 870.5150 | 2 | 71 |
| QEZ | Aspiration Thrombectomy Catheter | 870.5150 | 2 | 92 |
| DXF | Catheter, Septostomy | 870.5175 | 2 | 20 |
| QLZ | Septostomy Catheter, Reprocessed | 870.5175 | 2 | 2 |
| DRM | Compressor, Cardiac, External | 870.5200 | 2 | 45 |
| LIX | Aid, Cardiopulmonary Resuscitation | 870.5210 | 2 | 17 |
| PMJ | Cpr Aid Feedback Device (No Software) | 870.5210 | 2 | 0 |
| PMK | Cpr Aid Device Without Feedback | 870.5210 | 1 | 2 |
| DRN | Device, Counter-Pulsating, External | 870.5225 | 2 | 34 |
| DRK | Dc-Defibrillator, High Energy, (Including Paddles) | 870.5300 | 3 | 1 |
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 870.5300 | 2 | 166 |
| MPC | Atrial Defibrillator | 870.5300 | 3 | 0 |
| MPD | Auxiliary Power Supply (Ac Or Dc) For Low-Energy Dc-Defibrillator | 870.5300 | 2 | 3 |
| MKJ | Automated External Defibrillators (Non-Wearable) | 870.5310 | 3 | 245 |
| NSA | Over-The-Counter Automated External Defibrillator | 870.5310 | 3 | 2 |
| DRL | Tester, Defibrillator | 870.5325 | 2 | 19 |
| DRO | Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) | 870.5550 | 2 | 84 |
| MPE | Auxiliary Power Supply (Acor Dc) For External Transcutaneous Cardiac Pacemaker | 870.5550 | 2 | 1 |
| QMS | Adjunctive Open Loop Fluid Therapy Recommender | 870.5600 | 2 | 2 |
| PJB | Catheter Remote Control System | 870.5700 | 2 | 4 |
| QXU | Esophageal Protection Device For Use In Percutaneous Cardiac Catheter Ablation Procedures, Mechanical Deviation | 870.5710 | 2 | 2 |
| QXV | Temperature Regulation Device For Esophageal Protection During Cardiac Ablation | 870.5720 | 2 | 1 |
| JOW | Sleeve, Limb, Compressible | 870.5800 | 2 | 350 |
| LHX | Trousers, Anti-Shock | 870.5800 | 2 | 4 |
| PPS | Sleeve, Head And Neck, Compressible | 870.5800 | 2 | 1 |
| DWJ | System, Thermal Regulating | 870.5900 | 2 | 158 |
| NCX | System, Hypothermia, Intravenous, Cooling | 870.5900 | 2 | 26 |
| NZE | Hyperthermia Monitor | 870.5900 | 2 | 6 |
| PLA | Esophageal Thermal Regulation And Gastric Suctioning Device | 870.5910 | 2 | 9 |
| DRP | Tourniquet, Automatic Rotating | 870.5925 | 2 | 0 |
