Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010762

FEI Number

3009649876

Entity Name

MAQUET CARDIOPULMONARY GmbH

City/State/Country

Hechingen Baden-Wurttemberg, DE

Establishment Address

Neue Rottenburger Strasse 37, Hechingen Baden-Wurttemberg 72379, DE

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Maquet Cardiopulmonary GmbH (Owner Number: 8010762)

Owner / Operator Contact Address

Kehler Strasse 31, Rastatt, DE-BW 76437, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133598

PMA Number

N/A

All Registered Proprietary Names

QUADROX-iD Diffusion Membrane Oxygenators with Holding Clamp. HL-20 Integrated Perfusion System RotaFlow Centrifugal Pump RotaFlow Centrifugal Pump System HLS-Set Advanced 7 and 5 (with BIOLINE Coating) HIT-Set Advanced 7 and 5 (SOFTLINE Coating) HLS Cannulae, Non Coated, With BIOLINE OR SOFTLINE Coating Avalon Elite Bi-Caval Dual Lument Catheter RotaFlow Centrifugal Pump with BIOLINE Coating QUADROX-iD Adult w and w/o Bioline; QUADROX-i Small Adult with Bioline Holders, multiple Sprinter Cart (XL) CARDIOHELP-i and multiple accessories

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2014-01-15
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2014-01-15
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2014-01-15
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4220	1995-05-16
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2007-12-07
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	Class 2	870.4260	2015-11-10
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2015-11-10
DTR	Heat-Exchanger, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4240	2015-11-10
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2015-11-10
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2011-03-19
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4210	2012-06-14
KFM	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	Cardiovascular	Class 2	870.4360	2008-12-04
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4350	2015-08-25
KRI	Accessory Equipment, Cardiopulmonary Bypass	Cardiovascular	Class 1	870.4200	2001-09-18
DTQ	Console, Heart-Lung Machine, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4220	2014-07-28

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
3009507273	MAQUET CARDIOPULMONARY GmbH	Rastatt Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914791	Gish Biomedical, Inc.	GISH ARTERIAL FILTER	1993-04-06
K790435	Surgikos, Inc.	*INTERSEPT BLOOD FILTER W/ TUBING BYPASS**	1979-03-27
K832124	Med-West, Inc.	CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI	1983-08-12
K162500	Spyder Medical	Ostial Sprit Cannulae	2017-01-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2022	Medtronic Perfusion Systems	2	Medtronic Bio-Medicus Insertion Kits, Model number 96553, Pediatric Insertion Kit, Sterile; and Model number 96551, Venous Insertion Kit, Sterile.
Z-0021-2018	OriGen Biomedical, Inc.	2	The OriGen Reinforced Dual Lumen catheter (RDLC) is a duel lumen catheter with a wire reinforcement layer on the tip of the device. A thin sheath is used to cover and secure the wire layer and is heat shrunk into a permanent position.

Similar Registrations

Registration Number	Establishment Name	Location
2916596	THORATEC CORP.	PLEASANTON, CA, US
3019807891	CENTERPIECE S. DE R.L DE C.V (sterilization site)	Tijuana Baja California, MX
9680841	SORIN GROUP ITALIA S.R.L	MIRANDOLA Modena, IT
9617601	Medtronic Mexico S. de R.L. de CV	Tijuana Baja California, MX
2528981	LYNX Medical Pennsylvania	ERIE, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010762. Last updated year: 2026. Please use registration number 8010762 when referencing this establishment in official correspondence.