Pericardial Patch To Facilitate Revision Surgeries
The Pericardial Patch To Facilitate Revision Surgeries (product code OMH) is a Class 2 implantable cardiovascular device regulated under 21 CFR 870.3470 in the Cardiovascular specialty (CV), cleared via 510(k). It serves as a pericardial patch or pledget whose secondary function is to facilitate revision cardiac surgeries by providing a dissection plane, and is distinct from devices primarily intended to minimize adhesion formation. The device is flagged as both an implant and life-sustaining or life-supporting, reflecting its use in high-stakes cardiac surgery.
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Basic Information
- Product Code
- OMH
- Device Class
- FDA class 2
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K031785 | MACROPORE CARDIO-WRAP (TS) | Sep 04, 2003 | Substantially Equivalent | Macropore Biosurgery, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.