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Spiration Valve System

Gyrus Acmi, Llc · Model HUS-C26N · UDI-DI 00896506002187

OAZ
0
510(k) clearances
33
Adverse events (10 deaths)
0
Recalls
3
Facilities

Description

Deployment Catheter and Loader, 2.6

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.