OMH · Pericardial Patch To Facilitate Revision Surgeries
Cardiovascular · 21 CFR 870.3470 · Class 2
Overview
| Product Code | OMH |
|---|---|
| Device Name | Pericardial Patch To Facilitate Revision Surgeries |
| Regulation | 21 CFR 870.3470 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| Implant | Yes |
| Life-Sustaining | Yes |
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).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K031785 | MACROPORE CARDIO-WRAP (TS) | Macropore Biosurgery, Inc. | Sep 4, 2003 | SESE |
Top Applicants
- Macropore Biosurgery, Inc. — 1 clearance
