OMH
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Pericardial Patch To Facilitate Revision Surgeries
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3470
- Medical specialty
- Cardiovascular
- Flags
- Implant · Life-sustaining
- FDA definition
- Pericardial patch or pledget with the secondary function of facilitating revision surgeries by providing a plane of dissection. Does not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of cardiac surgery.
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| Record | Firm | Date |
|---|---|---|
| MACROPORE CARDIO-WRAP (TS) (K031785) | Macropore Biosurgery, Inc. | 2003-09-04 |
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