ClearanceBrief
Company ยท DE

Maquet Cardiopulmonary, AG

FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2015. Name variants (Inc, Corp, punctuation) are merged.

44510(k) clearances (0 in 12 months)
10recalls (4 in 12 months)
9recalls that name a 510(k)

Product codes

CodeDeviceRecords
DTZOxygenator, Cardiopulmonary Bypass13
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass13
DTNReservoir, Blood, Cardiopulmonary Bypass7
KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type5
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass4
DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line3
DTRHeat-Exchanger, Cardiopulmonary Bypass2
DWETubing, Pump, Cardiopulmonary Bypass2
KRIAccessory Equipment, Cardiopulmonary Bypass2
DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass1
DWCController, Temperature, Cardiopulmonary Bypass1
KDIDialyzer, High Permeability With Or Without Sealed Dialysate System1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
May 7, 2015K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators
Maquet Cardiopulmonary, AG, DE
DTZ
Nov 19, 2014K140569ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)
Maquet Cardiopulmonary, AG, DE
DWF
Jul 7, 2014K141432NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH
Maquet Cardiopulmonary, AG, DE
DTN
May 21, 2014K133598CARDIOHELP SYSTEM
Maquet Cardiopulmonary, AG
DTQ
Nov 12, 2013K133265QUADROX-IR ADULT AND SMALL ADULT
Maquet Cardiopulmonary, AG
KFM
Oct 30, 2013K132166VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT
Maquet Cardiopulmonary, AG, DE
DTN
Oct 8, 2013K132829QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
Maquet Cardiopulmonary, AG
DTZ
Jul 5, 2013K131666ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
Maquet Cardiopulmonary, AG, DE
DWF
Jul 1, 2013K130300HEATER-COOLER UNIT HCU 40
Maquet Cardiopulmonary, AG
DWC
Jun 26, 2013K123288HEMOCONCENTRATOR
Maquet Cardiopulmonary, AG, DE
KDI
May 16, 2013K130639ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER
Maquet Cardiopulmonary, AG, DE
DWF
Sep 15, 2011K112360QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES
Maquet Cardiopulmonary, AG, DE
DTZ
Apr 4, 2011K102726CARDIOHELP SYSTEM
Maquet Cardiopulmonary, AG, DE
DTQ
Mar 11, 2011K102919NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE
Maquet Cardiopulmonary, AG, DE
DTN
Mar 8, 2011K103191QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING
Maquet Cardiopulmonary, AG, DE
DTZ
Mar 4, 2011K102464QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING
Maquet Cardiopulmonary, AG, DE
DTZ
Feb 25, 2011K102532HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
Maquet Cardiopulmonary, AG, DE
DWF
Dec 8, 2010K101153QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD
Maquet Cardiopulmonary, AG, DE
DTZ
Apr 30, 2010K100278QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA
Maquet Cardiopulmonary, AG, DE
DTZ
Dec 23, 2009K090690VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING
Maquet Cardiopulmonary, AG, DE
DTN
Dec 23, 2009K090555PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
Maquet Cardiopulmonary, AG, DE
DTR
Dec 23, 2009K090534VENOUS HARDSHELL CARDIOTOMY RESERVIORS
Maquet Cardiopulmonary, AG, DE
DTN
Dec 18, 2009K090533HLM TUBING SET WITH SOFTLINE COATING
Maquet Cardiopulmonary, AG, DE
DWF
Dec 18, 2009K090518QUART ARTERIAL FILTER WITH SOFTLINE COATING
Maquet Cardiopulmonary, AG, DE
DTM
Dec 18, 2009K090515ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)
Maquet Cardiopulmonary, AG, DE
KFM
Dec 7, 2009K093522QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C
Maquet Cardiopulmonary, AG, DE
DTZ
Oct 29, 2009K090689QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000
Maquet Cardiopulmonary, AG, DE
DTZ
Jun 12, 2009K090511QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000
Maquet Cardiopulmonary, AG, DE
DTZ
Apr 22, 2009K090147BLOOD MONITORING UNIT, MODEL BMU 40
Maquet Cardiopulmonary, AG, DE
DRY
Apr 21, 2009K083794MECC SET WITH BIOLINE COATING
Maquet Cardiopulmonary, AG, DE
KFM
Feb 18, 2009K082117QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000
Maquet Cardiopulmonary, AG, DE
DTZ
Oct 3, 2008K082544QUART ARTERIAL FILTER WITH BIOLINE COATING
Maquet Cardiopulmonary, AG, DE
DTM
Sep 12, 2008K080470ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
Maquet Cardiopulmonary, AG, DE
KFM
Sep 11, 2008K080592HLM TUBING SET WITH BIOLINE COATING
Maquet Cardiopulmonary, AG, DE
DWE
Apr 4, 2008K072583PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30
Maquet Cardiopulmonary, AG, DE
DTR
Jan 23, 2008K071774JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030
Maquet Cardiopulmonary, AG, DE
DTZ
Jan 4, 2008K070605JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING
Maquet Cardiopulmonary, AG, DE
DTN
Aug 31, 2007K072172JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE
Maquet Cardiopulmonary, AG, DE
DWF
Aug 22, 2006K061628JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030
Maquet Cardiopulmonary, AG
DTZ
Aug 11, 2006K061832JOSTRA HLM TUBING SETS WITH SAFELINE COATING
Maquet Cardiopulmonary, AG
DWF
Jul 21, 2006K061743VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001
Maquet Cardiopulmonary, AG, DE
DTN
Jun 20, 2006K061546QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140
Maquet Cardiopulmonary, AG, DE
DTM
May 23, 2006K061072ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32
Maquet Cardiopulmonary, AG, DE
KFM
Nov 10, 2005K053025JOSTRA HLM TUBING SET
Maquet Cardiopulmonary, AG
DWE

Latest recalls

DateFirm and productCodeLinked 510(k)
Sep 11, 2026Maquet Cardiopulmonary Gmbh
Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS);
Open, Classified		 DWFK131666
Sep 11, 2026Maquet Cardiopulmonary Gmbh
Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
Open, Classified		 DWFK131666
Sep 11, 2026Maquet Cardiopulmonary Gmbh
Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
Open, Classified		 DWFK131666
Feb 5, 2026Maquet Cardiopulmonary Gmbh
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Open, Classified		 DTQK133598
Jul 29, 2025Maquet Cardiopulmonary Gmbh
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Open, Classified		 KRINone listed
May 27, 2025Maquet Cardiopulmonary Ag
Cardiohelp System HKH 8820 Wall Holder. Mounting bracket designed to hold the CARDIOHELP-i system for interhospital transport by vehicle.
Open, Classified		 DTQK102726
May 14, 2018Maquet Cardiopulmonary Ag
Aortic Arterial Cannula 24 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002267, Article Number A24-7107. For use in cardiopulmonary bypass
Terminated		 DWFK012774
May 14, 2018Maquet Cardiopulmonary Ag
Aortic Arterial Cannula 22 Fr (O.D.); 23 cm (L); with 3/8-inch connector with LL, Part Number 701002246, Article Number A22-7107. For use in cardiopulmonary bypass
Terminated		 DWFK012774
May 14, 2018Maquet Cardiopulmonary Ag
Aortic Arterial Cannula 20 Fr (O.D.); 23 cm (L); with 3/8-inch wide connector, Part Number 701002206, Article Number A20-0101. For use in cardiopulmonary bypass
Terminated		 DWFK012774
Apr 4, 2018Maquet Cardiopulmonary Ag
CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and require
Terminated		 KRIK102726
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