FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K982254 |
COBE CARDIOVASCULAR, INC. |
COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD |
09/10/1998 |
K002493 |
COBE CARDIOVASCULAR, INC. |
DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER |
11/30/2000 |
K040184 |
COBE CARDIOVASCULAR, INC. |
DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER |
02/26/2004 |
K031323 |
CONVERGENZA AG |
DBT, DYNAMIC BUBBLE TRAP |
08/01/2003 |
K041061 |
DIDECO S.P.A. |
D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS |
05/06/2004 |
K033987 |
DIDECO S.P.A. |
D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS |
01/08/2004 |
K051232 |
DIDECO S.R.L. |
D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER |
05/20/2005 |
K052717 |
DIDECO S.R.L. |
D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER |
10/20/2005 |
K062429 |
EDWARDS LIFESCIENCES RESEARCH MEDICAL |
MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH |
09/27/2006 |
K031946 |
EDWARDS LIFESCIENCES, LLC. |
EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE |
11/03/2003 |
K022071 |
EMBOL-X, INC. |
EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 |
02/14/2003 |
K023833 |
GISH BIOMEDICAL, INC. |
GISH ARTERIAL FILTER WITH GBS COATING |
03/31/2003 |
K081054 |
GISH BIOMEDICAL, INC. |
GISH ARTERIAL FILTER WITH HA COATING |
01/15/2009 |
K001787 |
JOSTRA MEDIZINTECHNIK AG |
QUART ARTERIAL FILTER, MODEL HBF 140 |
06/30/2000 |
K082544 |
MAQUET CARDIOPULMONARY AG |
QUART ARTERIAL FILTER WITH BIOLINE COATING |
10/03/2008 |
K061546 |
MAQUET CARDIOPULMONARY AG |
QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140 |
06/20/2006 |
K090518 |
MAQUET CARDIOPULMONARY AG |
QUART ARTERIAL FILTER WITH SOFTLINE COATING |
12/18/2009 |
K122760 |
MEDTRONIC INC. |
AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE |
12/07/2012 |
K100646 |
MEDTRONIC INC. |
AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE |
12/16/2010 |
K994208 |
MEDTRONIC PERFUSION SYSTEMS |
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354 |
01/13/2000 |
K033468 |
MEDTRONIC PERFUSION SYSTEMS |
AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE |
11/14/2003 |
K013084 |
MEDTRONIC PERFUSION SYSTEMS |
AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T |
09/27/2001 |
K123351 |
MEDTRONIC PERFUSION SYSTEMS |
AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE |
03/19/2013 |
K001138 |
MEDTRONIC VASCULAR |
AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354 |
04/27/2000 |
K071253 |
MEDTRONIC VASCULAR |
AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 |
07/03/2007 |
K000379 |
MEDTRONIC VASCULAR |
MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352 |
02/16/2000 |
K980762 |
PALL CORP. |
PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE |
09/01/1998 |
K112525 |
PAREXELINTERNATIONAL |
D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS |
09/29/2011 |
K961869 |
SORIN BIOMEDICAL, INC. |
DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 |
08/12/1996 |
K063255 |
SORIN GROUP ITALIA S.R.L |
D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED |
01/11/2007 |
K093986 |
SORIN GROUP ITALIA S.R.L. |
AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS |
01/22/2010 |
K093601 |
SORIN GROUP ITALIA S.R.L. |
AF 840 PH.I.S.I.O. ARTERIAL FILTER |
12/18/2009 |
K072308 |
SORIN GROUP ITALIA S.R.L. |
D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED |
09/12/2007 |
K052205 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
CAPIOX AF125X ARTERIAL FILTER |
09/12/2005 |
K011804 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X |
07/09/2001 |
K032128 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
TERUMO AL8X ARTERIAL FILTER WITH X-COATING |
08/01/2003 |
K083747 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
TERUMO PALL AL3X ARTERIAL FILTER |
08/20/2009 |
K083834 |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
TERUMO PALL AL6X ARTERIAL FILTER |
04/17/2009 |
K121209 |
Terumo Cardiovascular Systems Corporation |
TERUMO PALL AL20X ARTERIAL FILTER |
05/08/2012 |
K002026 |
TERUMO MEDICAL CORP. |
CAPIOX ARTERIAL FILTER |
09/06/2000 |