Part 870 Subpart D—Cardiovascular Prosthetic Devices
FDA submissions for Part 870 Subpart D—Cardiovascular Prosthetic Devices in the Cardiovascular (CV) review panel, including product codes and regulations.
Section range: §§ 870.3250–870.3955
CFR Part: 870
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| DSS | Clip, Vascular | 870.3250 | 2 | 8 |
| DST | Clip, Vena-Cava | 870.3260 | 2 | 1 |
| KRD | Device, Vascular, For Promoting Embolization | 870.3300 | 2 | 129 |
| NAJ | Agents, Embolic, For Treatment Of Uterine Fibroids | 870.3300 | 2 | 8 |
| QZU | Temporary Embolization Assist Device, Peripheral | 870.3325 | 2 | 1 |
| DTK | Filter, Intravascular, Cardiovascular | 870.3375 | 2 | 84 |
| PNS | Short-Term Intravascular Filter Catheter | 870.3375 | 2 | 1 |
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 870.3450 | 2 | 188 |
| DYF | Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | 870.3450 | 2 | 21 |
| MAB | Marker, Cardiopulmonary Bypass (Vein Marker) | 870.3450 | 2 | 3 |
| MAL | Graft, Vascular, Synthetic/Biologic Composite | 870.3450 | 2 | 8 |
| MZY | Graft, Vascular, Stainless Steel Tunneler | 870.3450 | 2 | 0 |
| OTD | Endovascular Suturing System | 870.3460 | 2 | 7 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 870.3470 | 2 | 90 |
| MFX | Vessel Guard Or Cover, To Facilitate Revision Surgeries | 870.3470 | 2 | 2 |
| OMH | Pericardial Patch To Facilitate Revision Surgeries | 870.3470 | 2 | 1 |
| OMR | Vessel Guard Or Cover | 870.3470 | 2 | 10 |
| PAW | Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement | 870.3470 | 2 | 3 |
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived | 870.3470 | 2 | 11 |
| SBK | Artificial Chordae Tendineae Surgical Replacement System | 870.3490 | 2 | 1 |
| DSP | System, Balloon, Intra-Aortic And Control | 870.3535 | 2 | 162 |
| NKO | System, Balloon, Intra-Aortic And Control, Reprocessed | 870.3535 | 3 | 0 |
| OKR | Ventricular Bypass (Assist) Device | 870.3545 | 3 | 0 |
| PCK | Pediatric Ventricular Assist Device | 870.3545 | f | 0 |
| DTE | Pulse-Generator, Pacemaker, External | 870.3600 | 2 | 65 |
| OVJ | Pulse Generator, External Pacemaker, Dual Chamber | 870.3600 | 2 | 0 |
| QAB | Pacing System Analyzer | 870.3605 | 2 | 0 |
| DSZ | Pacemaker Battery | 870.3610 | 3 | 0 |
| DXY | Implantable Pacemaker Pulse-Generator | 870.3610 | 3 | 471 |
| PNJ | Leadless Pacemaker | 870.3610 | 3 | 2 |
| DTD | Pacemaker Lead Adaptor | 870.3620 | 2 | 103 |
| DTC | Analyzer, Pacemaker Generator Function | 870.3630 | 2 | 30 |
| KRE | Analyzer, Pacemaker Generator Function, Indirect | 870.3640 | 2 | 13 |
| DSW | Bag, Polymeric Mesh, Pacemaker | 870.3650 | 1 | 0 |
| KRF | Charger, Pacemaker | 870.3670 | 1 | 0 |
| DTB | Permanent Pacemaker Electrode | 870.3680 | 3 | 490 |
| LDF | Electrode, Pacemaker, Temporary | 870.3680 | 2 | 128 |
| NHW | Electrode, Pacing And Cardioversion, Temporary, Epicardial | 870.3680 | 2 | 2 |
| DTG | Magnet, Test, Pacemaker | 870.3690 | 1 | 5 |
| KRG | Programmer, Pacemaker | 870.3700 | 3 | 25 |
| KFJ | Materials, Repair Or Replacement, Pacemaker | 870.3710 | 3 | 3 |
| DTA | Tester, Pacemaker Electrode Function | 870.3720 | 2 | 10 |
| DTF | Tools, Pacemaker Service | 870.3730 | 1 | 2 |
| KRH | Ring, Annuloplasty | 870.3800 | 2 | 74 |
| PST | Aortic Annuloplasty Ring | 870.3800 | 2 | 2 |
| DSR | Stimulator, Carotid Sinus Nerve | 870.3850 | 3 | 1 |
| DYE | Replacement Heart-Valve | 870.3925 | 3 | 8 |
| PAL | Pulmonic Replacement Heart Valve | 870.3925 | f | 0 |
| DTJ | Holder, Heart-Valve, Prosthesis | 870.3935 | 1 | 12 |
| MOP | Rotator, Prosthetic Heart Valve | 870.3935 | 1 | 4 |
| DTI | Sizer, Heart-Valve, Prosthesis | 870.3945 | 1 | 7 |
| QWA | Cardiovascular Delivery Catheter System Positioning And Stabilization Device | 870.3955 | 1 | 0 |
