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ShortCut

PI-CARDIA LTD · Model Z-A-20.003-US · UDI-DI 07290020101242

SCZ Prescription
1
510(k) clearances
17
Adverse events (7 deaths)
0
Recalls
3
Facilities

Description

Percutaneous catheter for cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.