FDA 510(k) Applications Submitted by MAQUET CARDIOPULMONARY AG

FDA 510(k) Number Submission Date Device Name Applicant
K090147 01/21/2009 BLOOD MONITORING UNIT, MODEL BMU 40 MAQUET CARDIOPULMONARY AG
K090511 02/26/2009 QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000 MAQUET CARDIOPULMONARY AG
K090515 02/26/2009 ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA) MAQUET CARDIOPULMONARY AG
K090534 02/27/2009 VENOUS HARDSHELL CARDIOTOMY RESERVIORS MAQUET CARDIOPULMONARY AG
K090555 03/02/2009 PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 MAQUET CARDIOPULMONARY AG
K093522 11/13/2009 QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE C MAQUET CARDIOPULMONARY AG
K130300 02/07/2013 HEATER-COOLER UNIT HCU 40 MAQUET CARDIOPULMONARY AG
K133598 11/22/2013 CARDIOHELP SYSTEM MAQUET CARDIOPULMONARY AG
K090518 02/26/2009 QUART ARTERIAL FILTER WITH SOFTLINE COATING MAQUET CARDIOPULMONARY AG
K090533 02/27/2009 HLM TUBING SET WITH SOFTLINE COATING MAQUET CARDIOPULMONARY AG
K090689 03/16/2009 QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000 MAQUET CARDIOPULMONARY AG
K132166 07/12/2013 VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT MAQUET CARDIOPULMONARY AG
K102532 09/03/2010 HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING MAQUET CARDIOPULMONARY AG
K123288 10/22/2012 HEMOCONCENTRATOR MAQUET CARDIOPULMONARY AG
K061628 06/12/2006 JOSTRA QUADROX D SAFELINE DIFFUSION MEMBRANE OXYGENATOR, MODEL HMOD 2030 MAQUET CARDIOPULMONARY AG
K061832 06/29/2006 JOSTRA HLM TUBING SETS WITH SAFELINE COATING MAQUET CARDIOPULMONARY AG
K053025 10/27/2005 JOSTRA HLM TUBING SET MAQUET CARDIOPULMONARY AG
K080470 02/21/2008 ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32 MAQUET CARDIOPULMONARY AG
K080592 03/03/2008 HLM TUBING SET WITH BIOLINE COATING MAQUET CARDIOPULMONARY AG
K072172 08/06/2007 JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAE MAQUET CARDIOPULMONARY AG
K061072 04/17/2006 ROTAFLOW CENTRIFUGAL PUMP WITH SAFELINE COATING, MODEL BSQ-RF-32 MAQUET CARDIOPULMONARY AG
K100278 02/01/2010 QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA MAQUET CARDIOPULMONARY AG
K070605 03/05/2007 JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATING MAQUET CARDIOPULMONARY AG
K130639 03/11/2013 ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER MAQUET CARDIOPULMONARY AG
K090690 03/16/2009 VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING MAQUET CARDIOPULMONARY AG
K101153 04/23/2010 QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMOD MAQUET CARDIOPULMONARY AG
K141432 05/30/2014 NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH MAQUET CARDIOPULMONARY AG
K061546 06/05/2006 QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140 MAQUET CARDIOPULMONARY AG
K061743 06/21/2006 VENOUS HARDSHELL CARDIOTOMY RESERVOIR W/SAFELINE COATING, MODEL BSQ-VHK 2000;VACUUM TIGHT, MODEL BSQ-VHK 2001 MAQUET CARDIOPULMONARY AG
K071774 06/29/2007 JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030 MAQUET CARDIOPULMONARY AG
K082117 07/28/2008 QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000 MAQUET CARDIOPULMONARY AG
K112360 08/17/2011 QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES MAQUET CARDIOPULMONARY AG
K102464 08/27/2010 QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING MAQUET CARDIOPULMONARY AG
K082544 09/03/2008 QUART ARTERIAL FILTER WITH BIOLINE COATING MAQUET CARDIOPULMONARY AG
K072583 09/13/2007 PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30 MAQUET CARDIOPULMONARY AG
K102919 10/01/2010 NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHE MAQUET CARDIOPULMONARY AG
K103191 10/28/2010 QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING MAQUET CARDIOPULMONARY AG
K083794 12/22/2008 MECC SET WITH BIOLINE COATING MAQUET CARDIOPULMONARY AG
K102726 09/21/2010 CARDIOHELP SYSTEM MAQUET CARDIOPULMONARY AG
K140569 03/06/2014 ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) MAQUET CARDIOPULMONARY AG
K131666 06/07/2013 ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING MAQUET CARDIOPULMONARY AG
K150267 02/04/2015 QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators MAQUET CARDIOPULMONARY AG
K132829 09/09/2013 QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS MAQUET CARDIOPULMONARY AG
K133265 10/23/2013 QUADROX-IR ADULT AND SMALL ADULT MAQUET CARDIOPULMONARY AG


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