FDA product code DYE
Replacement Heart-Valve
Cardiovascular·Class 3·21 CFR 870.3925·Implantable
US regulatory classifications
- US Product Code (FDA)
- DYEView Product Code Classification →
- US Risk Class (FDA)
- Class 3
- US Regulation (CFR)
- 21 CFR 870.3925View CFR Regulation →
- Medical specialty
- Cardiovascular
Device characteristics
- GMP exempt
- No
- Implantable
- Yes
- Life-sustaining
- No
- Third party review
- Not Eligible
Definition
Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))
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About this record
Replacement Heart-Valve 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.
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.