FDA product code NPT

Aortic Valve, Prosthesis, Percutaneously Delivered

Unknown·Class 3·21 CFR ·Implantable·Life-sustaining
US regulatory classifications
US Product Code (FDA)
NPT
View Product Code Classification →
US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR
View CFR Regulation →
Medical specialty
Unknown
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
Yes
Third party review
Not Eligible
Definition

To replace a patient's aortic heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.

Search keywords
About this record

Aortic Valve, Prosthesis, Percutaneously Delivered is a medical device type in the Unknown 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.