Pericardial Patch To Facilitate Revision Surgeries
- US Product Code (FDA)
- OMHView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 870.3470View CFR Regulation →
- Medical specialty
- Cardiovascular
- GMP exempt
- No
- Implantable
- Yes
- Life-sustaining
- Yes
- Third party review
- Not Eligible
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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Pericardial Patch To Facilitate Revision Surgeries is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes implantable products. This device type includes life-sustaining products.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.