Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030471525

FEI Number

3030471525

Entity Name

PI-CARDIA LTD

City/State/Country

Rehovot Central, IL

Establishment Address

David Fikes 5, Rehovot Central 7632805, IL

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Pi-Cardia LtD (Owner Number: 10091623)

Owner / Operator Contact Address

David Fikes 5, Rehovot, IL-M 7632805, IL

Initial Importer Flag

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

Marybeth Gamber Email: marybeth@gamberconsultants.com Phone: (774) 2495250

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
3033307537	Pi-Cardia Inc	Cambridge, MA, US

Similar Registrations

Registration Number	Establishment Name	Location
3033307537	Pi-Cardia Inc	Cambridge, MA, US
3008729892	MEDIPLAST ISRAEL LTD	Yavne Tel Aviv, IL
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN
3038274470	BRAINMATTERZ, INC	McKinney, TX, US
3012404174	LABORATORIO CHIMICO FARMACEUTICO A. SELLA SRL.	Schio Vicenza, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030471525. Last updated year: 2026. Please use registration number 3030471525 when referencing this establishment in official correspondence.