Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004582654

FEI Number

3004582654

Entity Name

BERLIN HEART GMBH

City/State/Country

Berlin, DE

Establishment Address

Wiesenweg 10, Steglitz, Berlin D-12247, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Berlin Heart GmbH (Owner Number: 10039961)

Owner / Operator Contact Address

Weisenweg 10, Steglitz, Berlin, DE-BE D-12247, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

H100004

All Registered Proprietary Names

EXCOR Pediatric Ventricular Assist Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PCK	Pediatric Ventricular Assist Device	Cardiovascular	Class f	870.3545	2012-03-02
DSQ	Ventricular (Assist) Bypass	Unknown	Class 3	N/A	2012-03-02

Official Correspondent

No official correspondent registered.

US Agent Details

Robert Kroslowitz Business: Berlin Heart, Inc. Email: rkroslowitz@berlinheartinc.com Phone: (281) 8639700

Related Public Records

Same Entity

Berlin Heart GmbH

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2007	Thoratec Corp	3	Thoratec brand TLC-II Portable Ventricular Assist Device (VAD) Driver; Catalog No. 20010-2085-000 Distributed and Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
Z-0005-2017	Heartware, Inc.	3	HeartWare Ventricular Assist System Controller Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. The HVAD is designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter
Z-0006-2017	HeartWare, Inc	3	HeartWare Ventricular Assist System (HVAD), US product: Model No.: 1103; and International Product: Model No.: 1104XX. Product Usage: For use as a bridge-to-cardiac transplantation in patients who are at risk of death from refractory end-stage left ventricular heart failure. Designed for in-hospital and out-of-hospital settings, including transportation via fix-wing aircraft or helicopter.
Z-0015-2007	Thoratec Corp	3	Thoratec brand Sealed Arterial Cannula for use with the Thoratec Vascular Assist Device System, Model Number(s): Catalogue numbers: #100118-- Short, 14mm graft; #100121-- Long, 14mm graft; #100129-- Long, 18mm graft. Manufactured by Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588

Similar Registrations

Registration Number	Establishment Name	Location
3008454189	BERLIN HEART, INC.	The Woodlands, TX, US
3007042319	HeartWare, Inc.	Miami Lakes, FL, US
2916596	THORATEC CORP.	PLEASANTON, CA, US
2134470	LOWELL,INC.	Brooklyn Park, MN, US
3012931014	INVENTUS POWER	Woodridge, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004582654. Last updated year: 2026. Please use registration number 3004582654 when referencing this establishment in official correspondence.