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

Heart-Valve, Non-Allograft Tissue

Unknown
FDA source (opens on fda.gov)

LWR is the FDA product code for Heart-Valve, Non-Allograft Tissue, a class III device type. As of , FDA records hold no 510(k) clearances under this code and 7 recalls.

Classification record

Product code
LWR
Device name
Heart-Valve, Non-Allograft Tissue
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
7

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order