Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9680759

FEI Number

3002807088

Entity Name

GLYCAR SA PTY., LTD.

City/State/Country

IRENE Gauteng, ZA

Establishment Address

1 ALBERT RD., BOX 967, IRENE Gauteng 0062, ZA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GLYCAR S.A (Owner Number: 9011207)

Owner / Operator Contact Address

1 ALBERT RD., --, IRENE, ZA-GT 0062, ZA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K963967

PMA Number

N/A

All Registered Proprietary Names

St. Jude Pericardial Patch w/Encap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2008-08-29

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

GLYCAR S.A

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9680759. Last updated year: 2026. Please use registration number 9680759 when referencing this establishment in official correspondence.