Pi-Cardia Inc

FDA Device Registration & Listing · Cambridge, MA, US · Registration 3033307537

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3033307537
FEI Number
3033307537
Entity Name
Pi-Cardia Inc
City/State/Country
Cambridge, MA, US
Establishment Address
1 Broadway Ct, Cambridge, MA 02138, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Pi-Cardia LtD (Owner Number: 10091623)
Owner / Operator Contact Address
David Fikes 5, Rehovot, IL-M 7632805, IL
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
DEN240017
PMA Number
N/A

All Registered Proprietary Names

ShortCut

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
SCZ Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures Cardiovascular Class 2 870.1254 2024-10-21

Official Correspondent

Hadas Givon

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Pi-Cardia LtD
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3030471525 PI-CARDIA LTD Rehovot Central, IL

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3033307537. Last updated year: 2026. Please use registration number 3033307537 when referencing this establishment in official correspondence.
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