FDA.reportPublic FDA data

MAQUET CARDIOPULMONARY GmbH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80107623009649876MAQUET CARDIOPULMONARY GmbH1N2026-01-01Neue Rottenburger Strasse 37 Hechingen Baden-Wurttemberg DE 72379
30095072733009507273MAQUET CARDIOPULMONARY GmbH1N2026-01-01Kehler Strasse 31 Rastatt Baden-Wurttemberg DE 76437
30147667923014766792Maquet Cardiopulmonary GmbH1N2020-04-25Grabenstr. 25 Bodelshausen Baden-Wurttemberg DE 72411

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
401691796151223K991864ROTAFLOW CENTRIFUGAL PUMP SYSTEMKFM2000-08-31
1480561796151223K991864ROTAFLOW CENTRIFUGAL PUMP SYSTEMKFM2000-08-31
401691620487470K984338JOSTRA HL-20 TWIN PUMPDPW1999-08-19
1480561620487470K984338JOSTRA HL-20 TWIN PUMPDPW1999-08-19
401691831410499K943803JOSTRA HL-20 INTEGRATED PERFUSION SYSTEMDTQ1996-01-30
1480561831410499K943803JOSTRA HL-20 INTEGRATED PERFUSION SYSTEMDTQ1996-01-30
401691996671251K874853POLYSTAN TWO STAGE CATHETERSDWF1988-02-05
401691599595809K874852POLYSTAN WIRE REINFORCED TWO STAGE CATHETERSDWF1988-02-05
401691398867824K872182POLYSTAN WIRE REINFORCED CATHETERS AND CANNULAEDQY1987-10-30
401691872487018K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult OxygenatorsDTZ2015-05-07
401691516004775K141432NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSHDTN2014-07-07
401691388677469K140569ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE)DWF2014-11-19
1480561838228534K133598CARDIOHELP SYSTEMDTQ2014-05-21
401691838228534K133598CARDIOHELP SYSTEMDTQ2014-05-21
401691021743883K133265QUADROX-IR ADULT AND SMALL ADULTKFM2013-11-12
401691926672839K132829QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORSDTZ2013-10-08
401691573286183K132166VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHTDTN2013-10-30
401691613942150K131666ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATINGDWF2013-07-05
401691605471816K130639ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETERDWF2013-05-16
401691389474008K123288HEMOCONCENTRATORKDI2013-06-26
401691194203759K112360QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIESDTZ2011-09-15
401691226647015K103191QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATINGDTZ2011-03-08
401691883699878K102919NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHEDTN2011-03-11
401691833588579K102726CARDIOHELP SYSTEMDTQ2011-04-04
1480561833588579K102726CARDIOHELP SYSTEMDTQ2011-04-04
401691392357607K102532HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATINGDWF2011-02-25
401691362107543K102464QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATINGDTZ2011-03-04
401691982609934K101153QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMODDTZ2010-12-08
401691689717964K100278QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USADTZ2010-04-30
1480561689717964K100278QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USADTZ2010-04-30
401691768632999K093522QUADROX-I SMALL ADULT MICROPOROUS MEMBRANE OXYGENATOR; W/ BIOLINE COATING AND W/ INTEGRATED ARTERIAL FILTER W/ BIOLINE CDTZ2009-12-07
401691064531786K090690VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATINGDTN2009-12-23
401691560396950K090689QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000DTZ2009-10-29
401692011886365K090555PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30DTR2009-12-23
401691542591850K090534VENOUS HARDSHELL CARDIOTOMY RESERVIORSDTN2009-12-23
401691203026483K090533HLM TUBING SET WITH SOFTLINE COATINGDWF2009-12-18
401691282846833K090518QUART ARTERIAL FILTER WITH SOFTLINE COATINGDTM2009-12-18
401691499829948K090515ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)KFM2009-12-18
401691187341599K090511QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000DTZ2009-06-12
1480561862689278K090147BLOOD MONITORING UNIT, MODEL BMU 40DRY2009-04-22
401691862689278K090147BLOOD MONITORING UNIT, MODEL BMU 40DRY2009-04-22
401691041026008K082544QUART ARTERIAL FILTER WITH BIOLINE COATINGDTM2008-10-03
401691539198476K082412VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160DTP2008-11-10
401691483347704K082117QUADROX-I ADULT WITH AND WITHOUT INTEGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODEL# HMO 70000, HMO 71000DTZ2009-02-18
401691730586852K081940AVALON ELITE VASCULAR ACCESS KITDRE2008-11-18
401691900406090K081820AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FRDWF2008-10-06
401691142849284K080592HLM TUBING SET WITH BIOLINE COATINGDWE2008-09-11
401691819973406K080470ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32KFM2008-09-12
401691402598089K072583PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30DTR2008-04-04
401691078530681K072172JOSTRA PEDIATRIC ARTERIAL PREFUSION CANNULAEDWF2007-08-31
401691788505017K070605JOSTRA VENOUS SOFTBAG RESERVOIRS WITH AND WITHOUT SAFELINE COATINGDTN2008-01-04
401691537518904K053025JOSTRA HLM TUBING SETDWE2005-11-10
1480561785879027K031544HEATER COOLER UNIT, MODEL HCU 30DWC2003-08-07
401691785879027K031544HEATER COOLER UNIT, MODEL HCU 30DWC2003-08-07
401692060017322K023251PEDIATRIC ARTERIAL CANNULADWF2002-12-04
401691364324621K022022JOSTRA VENT CATHETERS, MODELS LV & HKVDWF2002-09-11
401691931424936K020983JOSTRA SUCKERS, MODEL JSDWF2004-01-30
401691407946618K020784JOSTRA SINGLE STAGE VENOUS RETURN CATHETERSDWF2003-01-09
401691179187195K020515JOSTRA ANTEGRADE CARDIOPLEGIA CANNULADWF2002-04-24
401691421405896K014303JOSTRA RETROGRADE CARDIOPLEGIA CANNULAEDWF2002-03-26
401691688056382K013944JOSTRA DUAL STAGE VENOUS RETURN CANNULAEDWF2002-02-11
401691942254460K012774JOSTRA ARTERIAL PERFUSION CANNULAEDWF2001-11-16
401691160005230K012617JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A...DWF2001-11-06
401691803110188K002857ELS CANNULA (KIT), MODEL M1210-88,M1510-88DWF2000-10-05
401691345296458K001787QUART ARTERIAL FILTER, MODEL HBF 140DTM2000-06-30
1480561049342234
401691049342234
2217691144332837
1480561623906716
401691623906716
1480561629818973
401691629818973

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DWF222014-11-19
DTZ132015-05-07
DTQ82014-05-21
DTN62014-07-07
KFM52013-11-12
DTM32009-12-18
DTR22009-12-23
DRY22009-04-22
DRE22008-11-18
DWE22008-09-11
DWC22003-08-07
DPW21999-08-19
KDI12013-06-26
DTP12008-11-10
DQY11987-10-30