510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NPTClass III

Aortic Valve, Prosthesis, Percutaneously Delivered

Unknown
FDA source (opens on fda.gov)

NPT is the FDA product code for Aortic Valve, Prosthesis, Percutaneously Delivered, a class III device type. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and 33 recalls.

Classification record

Product code
NPT
Device name
Aortic Valve, Prosthesis, Percutaneously Delivered
FDA 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.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
33

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order