Data / Medical devices / Germany / MAQUET CARDIOPULMONARY GmbH

MAQUET CARDIOPULMONARY GmbH: FDA-registered device maker in Hechingen Baden-Wurttemberg, Germany, 14 510(k) clearances

Name: MAQUET CARDIOPULMONARY GmbH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

MAQUET CARDIOPULMONARY GmbH is registered with the FDA (registration 8010762) in Hechingen Baden-Wurttemberg, Germany. It lists 9 device types. The FDA files 14 510(k) clearances under its listings, the newest dated May 7, 2015. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 8010762
FEI number: 3009649876
Address: Neue Rottenburger Strasse 37, Hechingen Baden-Wurttemberg, Germany, 72379
Owner or operator: Maquet Cardiopulmonary GmbH (8010762)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: May 16, 1995
Registered through: 2026
Brand names listed: Arterial HLS-Cannula, 13 Fr., Non-Coated, With BIOLINE And With SOFTLINE Coating, Avalon Elite Bi-Caval Dual Lument Catheter, Avalon Elite Vascular Access Kit, CARDIOHELP-i and multiple accessories, HIT-Set Advanced 7 and 5 (SOFTLINE Coating), HIT-Set Advanced 7 and 5 (with SOFTLINE Coating);, HL-20 Integrated Perfusion System, HL-20 Twin Pump and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory Equipment, Cardiopulmonary Bypass	KRI	1	Manufacturer	accessdata.fda.gov
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	DWF	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Console, Heart-Lung Machine, Cardiopulmonary Bypass	DTQ	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Dilator, Vessel, For Percutaneous Catheterization	DRE	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Filter, Blood, Cardiopulmonary Bypass, Arterial Line	DTM	2	Manufacturer	accessdata.fda.gov
Flowmeter, Blood, Cardiovascular	DPW	2	Complaint file establishment	accessdata.fda.gov
Heat-Exchanger, Cardiopulmonary Bypass	DTR	2	Manufacturer	accessdata.fda.gov
Oxygenator, Cardiopulmonary Bypass	DTZ	2	Manufacturer	accessdata.fda.gov
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type	KFM	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 7, 2015	K150267	QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators	DTZ	Substantially Equivalent	Maquet Cardiopulmonary, AG	accessdata.fda.gov
May 21, 2014	K133598	CARDIOHELP SYSTEM	DTQ	Substantially Equivalent	Maquet Cardiopulmonary, AG	accessdata.fda.gov
October 8, 2013	K132829	QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS	DTZ	Substantially Equivalent	Maquet Cardiopulmonary, AG	accessdata.fda.gov
July 5, 2013	K131666	ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING	DWF	Substantially Equivalent	Maquet Cardiopulmonary, AG	accessdata.fda.gov
September 15, 2011	K112360	QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES	DTZ	Substantially Equivalent	Maquet Cardiopulmonary, AG	accessdata.fda.gov
April 4, 2011	K102726	CARDIOHELP SYSTEM	DTQ	Substantially Equivalent	Maquet Cardiopulmonary, AG	accessdata.fda.gov
February 25, 2011	K102532	HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING	DWF	Substantially Equivalent	Maquet Cardiopulmonary, AG	accessdata.fda.gov
April 30, 2010	K100278	QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA	DTZ	Substantially Equivalent	Maquet Cardiopulmonary, AG	accessdata.fda.gov
November 18, 2008	K081940	AVALON ELITE VASCULAR ACCESS KIT	DRE	Substantially Equivalent	Avalon Laboratories, LLC	accessdata.fda.gov
October 6, 2008	K081820	AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR	DWF	Substantially Equivalent	Avalon Laboratories, LLC	accessdata.fda.gov
September 12, 2008	K080470	ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32	KFM	Substantially Equivalent	Maquet Cardiopulmonary, AG	accessdata.fda.gov
August 31, 2000	K991864	ROTAFLOW CENTRIFUGAL PUMP SYSTEM	KFM	Substantially Equivalent	Jostra Medizintechnik AG	accessdata.fda.gov
August 19, 1999	K984338	JOSTRA HL-20 TWIN PUMP	DPW	Substantially Equivalent	Jostra Bentley	accessdata.fda.gov
January 30, 1996	K943803	JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM	DTQ	Substantially Equivalent	Janus Biomedical, Inc.	accessdata.fda.gov

Compare with other makers

Updated May 7, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.