INVENTUS POWER

FDA Device Registration & Listing · Woodridge, IL, US · Registration 3012931014

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
3012931014
FEI Number
3012931014
Entity Name
INVENTUS POWER
City/State/Country
Woodridge, IL, US
Establishment Address
1200 International Pkwy., Woodridge, IL 60517, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Inventus Power (Owner Number: 10052385)
Owner / Operator Contact Address
1200 International Pkwy., Woodridge, IL 60517, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Heartmate Medtronic HVAD

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DSQ Ventricular (Assist) Bypass Unknown Class 3 N/A 2021-01-28
DSQ Ventricular (Assist) Bypass Unknown Class 3 N/A 2021-01-20

Official Correspondent

Brian Sidor

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Inventus Power
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3013154126 Inventus Power, Inc. Dongguan City P.R. Guangdong, CN

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

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3007042319 HeartWare, Inc. Miami Lakes, FL, US
2916596 THORATEC CORP. PLEASANTON, CA, US
2134470 LOWELL,INC. Brooklyn Park, MN, 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 3012931014. Last updated year: 2026. Please use registration number 3012931014 when referencing this establishment in official correspondence.
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