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

Percutaneously Delivered Prostheses And Tricuspid Valves

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FDA source (opens on fda.gov)

NPW is the FDA product code for Percutaneously Delivered Prostheses And Tricuspid Valves, a class III device type. FDA's definition for this code reads: "These devices are intended to replace a patient's tricuspid heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously 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 one recall.

Classification record

Product code
NPW
Device name
Percutaneously Delivered Prostheses And Tricuspid Valves
FDA definition
These devices are intended to replace a patient's tricuspid heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously 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
1

Companies listing this code with FDA

Companies whose registered establishments list this code