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Maquet Cardiopulmonary, AG

FDA 510(k) & PMA Approved Devices — 40 products

Total Devices40
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K133265 QUADROX-IR ADULT AND SMALL ADULTKFM2013-11-12 View
510(k) K132166 VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHTDTN2013-10-30 View
510(k) K132829 QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORSDTZ2013-10-08 View
510(k) K131666 ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATINGDWF2013-07-05 View
510(k) K130300 HEATER-COOLER UNIT HCU 40DWC2013-07-01 View
510(k) K123288 HEMOCONCENTRATORKDI2013-06-26 View
510(k) K130639 ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETERDWF2013-05-16 View
510(k) K112360 QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIESDTZ2011-09-15 View
510(k) K102726 CARDIOHELP SYSTEMDTQ2011-04-04 View
510(k) K102919 NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVOIR, PEDIATRIC VENOUS HARDSHELL CARSIOTOMY RESERVOIR, NEONATAL VENOUS HARDSHEDTN2011-03-11 View
510(k) K103191 QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATINGDTZ2011-03-08 View
510(k) K102464 QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATINGDTZ2011-03-04 View
510(k) K102532 HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATINGDWF2011-02-25 View
510(k) K101153 QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR WITH SOFTLINE COATING, MODEL: BE-HMOD 70000-USA, BEQ-HMOD 70000-USA, HMODDTZ2010-12-08 View
510(k) K100278 QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USADTZ2010-04-30 View
510(k) K090690 VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATINGDTN2009-12-23 View
510(k) K090555 PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30DTR2009-12-23 View
510(k) K090534 VENOUS HARDSHELL CARDIOTOMY RESERVIORSDTN2009-12-23 View
510(k) K090518 QUART ARTERIAL FILTER WITH SOFTLINE COATINGDTM2009-12-18 View
510(k) K090515 ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)KFM2009-12-18 View
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