21 CFR 870.3470 — Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Cardiovascular (CV) · Part 870 Subpart D—Cardiovascular Prosthetic Devices · § 870.3470
Identification
An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.
Classification Rationale
Class II (performance standards).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | 90 | Implant |
| MFX | Vessel Guard Or Cover, To Facilitate Revision Surgeries | 2 | 2 | |
| OMH | Pericardial Patch To Facilitate Revision Surgeries | 2 | 1 | Implant, Life-Sustaining |
| OMR | Vessel Guard Or Cover | 2 | 10 | Implant |
| PAW | Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement | 2 | 3 | Implant, Life-Sustaining |
| PSQ | Intracardiac Patch Or Pledget, Biologically Derived | 2 | 11 | Implant |
