FDA 510(k) Applications for Medical Device Product Code "DTM"
(Filter, Blood, Cardiopulmonary Bypass, Arterial Line)
| 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 |
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