MAQUET CARDIOPULMONARY GmbH

FDA Device Registration & Listing · Rastatt Baden-Wurttemberg, DE · Registration 3009507273

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
3009507273
FEI Number
3009507273
Entity Name
MAQUET CARDIOPULMONARY GmbH
City/State/Country
Rastatt Baden-Wurttemberg, DE
Establishment Address
Kehler Strasse 31, Rastatt Baden-Wurttemberg 76437, DE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Maquet Cardiopulmonary GmbH (Owner Number: 8010762)
Owner / Operator Contact Address
Kehler Strasse 31, Rastatt, DE-BW 76437, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K991864
PMA Number
N/A

All Registered Proprietary Names

HL-20 Integrated Perfusion System CARDIOHELP-i and multiple accessories HL-20 Twin Pump QUADROX-iD Pediatric Diffusion Membrane Oxygenator with BIOLINE Coating RotaFlow Centrifugal Pump RotaFlow Centrifugal Pump System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 1995-05-16
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass Cardiovascular Class 2 870.4220 2014-07-28
DPW Flowmeter, Blood, Cardiovascular Cardiovascular Class 2 870.2100 2007-12-10
DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular Class 2 870.4350 2010-05-05
KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Cardiovascular Class 2 870.4360 2007-12-07

Official Correspondent

Tom Peters

US Agent Details

Emily Valerio Email: emily.valerio@getinge.com Phone: (862) 2215193

Related Public Records

Same Entity

Maquet Cardiopulmonary GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
8010762 MAQUET CARDIOPULMONARY GmbH Hechingen Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K903633 Transonic Systems, Inc. ADVANCE LASER FLOWMETER, ALF 21 1990-10-09
K182494 Laser Associated Sciences, Inc. FlowMet-R 2019-02-27

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9611109 LivaNova Deutschland GmbH MUNCHEN Bavaria, DE
8010762 MAQUET CARDIOPULMONARY GmbH Hechingen Baden-Wurttemberg, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009507273. Last updated year: 2026. Please use registration number 3009507273 when referencing this establishment in official correspondence.
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