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

Tricuspid Valve Repair Device, Percutaneously Delivered

Unknown
FDA source (opens on fda.gov)

NPS is the FDA product code for Tricuspid Valve Repair Device, Percutaneously Delivered, a class III device type. FDA's definition for this code reads: "These devices are intended to repair heart valves by methods other than that used by the classified device (annuloplasty rings). They may be placed using non-traditional techniques or other novel methods for decreasing valvular regurgitation". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
NPS
Device name
Tricuspid Valve Repair Device, Percutaneously Delivered
FDA definition
These devices are intended to repair heart valves by methods other than that used by the classified device (annuloplasty rings). They may be placed using non-traditional techniques or other novel methods for decreasing valvular regurgitation.
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
0

Companies listing this code with FDA

Companies whose registered establishments list this code