OMH — Pericardial Patch To Facilitate Revision Surgeries Class II
FDA product code OMH covers "Pericardial Patch To Facilitate Revision Surgeries", a Class II medical device regulated under 21 CFR 870.3470. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- OMH
- Device Class
- Class II
- Regulation Number
- 870.3470
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K031785 | macropore biosurgery | MACROPORE CARDIO-WRAP (TS) | September 4, 2003 |