Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007042319

FEI Number

3007042319

Entity Name

HeartWare, Inc.

City/State/Country

Miami Lakes, FL, US

Establishment Address

14400 NW 60th Ave, Miami Lakes, FL 33014, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medtronic, Inc. (Owner Number: 2112641)

Owner / Operator Contact Address

710 Medtronic Parkway, Minneapolis, MN 55432, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P100047

All Registered Proprietary Names

HeartWare Ventricular Assist System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSQ	Ventricular (Assist) Bypass	Unknown	Class 3	N/A	2016-09-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtronic, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3004497303	MEDTRONIC MEXICO EG	EMPALME Sonora, MX
3015192387	CATHWORKS	Newport Beach, CA, US
3004185781	Medtronic, Inc.	Tempe, AZ, US
3012520654	MEDTRONIC, INC.	Billerica, MA, US
3004594267	Medtronic Care Management Services	Lafayette, CO, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K103464	Medtronic, Inc.	PACIFIC XTREME PTCA BALLOON DILATATION CATHETER	2010-12-22
K111339	Medtronic, Inc.	HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)	2011-06-08

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-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-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
2916596	THORATEC CORP.	PLEASANTON, CA, US
2134470	LOWELL,INC.	Brooklyn Park, MN, US
3012931014	INVENTUS POWER	Woodridge, IL, US
3008792657	Thoratec Corporation	San Ramon, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007042319. Last updated year: 2026. Please use registration number 3007042319 when referencing this establishment in official correspondence.