FDA 510(k) Applications Submitted by KATRIN SCHWENKGLENKS
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K030264 |
01/27/2003 |
QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 |
JOSTRA 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 |
| K082412 |
08/21/2008 |
VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 |
MAPQUET 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 |
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