PI-CARDIA LTD

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30304715253030471525PI-CARDIA LTD1N2026-01-01David Fikes 5 Rehovot Central IL 7632805
30333075373033307537Pi-Cardia Inc1Y2026-01-011 Broadway Ct Cambridge MA US 02138

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
07290020101242ShortCut - Percutaneous catheter for cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures.888) 705-5366customerservice@pi-cardia.net

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3324691506217474DEN240017ShortCutSCZ2024-09-27
3333151506217474DEN240017ShortCutSCZ2024-09-27

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
SCZ22024-09-27

GUDID