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
K830131 AMERICAN BENTLEY ARTERIAL BLOOD FILTER AF-1025-AF-1025BL 01/28/1983
K830132 AMERICAN BENTLEY ARTERIAL BLOOD FILTER AF-1040-AF-1040BL 01/28/1983
K842813 AMERICAN BENTLEY HEPARIN COATED ARTERIAL BLOOD FILTERS 01/08/1985
K840612 AMERICAN BENTLEY PEDIATRIC ARTERIAL BLOOD FILTER 04/17/1984
K833048 AMERICAN BENTLEY PURGES LINES, PL-45 & PL-33 10/20/1983
K875080 AMERICAN OMNI MEDICAL, INC. AIR VENT LINE CAT. NO. AVL-36 02/29/1988
K873316 AMERICAN OMNI MEDICAL, INC. BUBBLE TRAP-FILTER CAT. NO B180F37 07/14/1988
K952532 AVECOR CARDIOVASCULAR, INC. AFFINITY ARTERIAL BLOOD FILTER 10/06/1995
K820343 BENTLEY LABORATORIES, INC. ARTERIAL BLOOD FILTER MODEL #AF-1040 06/17/1982
K820044 BENTLEY LABORATORIES, INC. ARTERIAL BLOOD FILTER, #AF-1025 06/29/1982
K792450 BENTLEY LABORATORIES, INC. ARTERIAL BLOOD FILTER, MODEL AF-10 12/19/1979
K820045 BENTLEY LABORATORIES, INC. CARDIOVASCULAR DEVICES 01/29/1982
K801147 BENTLEY LABORATORIES, INC. PEDIATRIC ARTERIAL BLOOD FILTER #AF-5 06/04/1980
K820679 BENTLEY LABORATORIES, INC. PEDIATRIC ARTERIAL BLOOD FILTER #AF-540 06/17/1982
K831507 C.R. BARD, INC. LOW TRAUMA ARTERIAL FILTER H-640 12/29/1983
K820472 C.R. BARD, INC. WILLIAM HARVEY H-625 ARTERIAL FILTER 03/15/1982
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
K900758 COBE LABORATORIES, INC. HEPARINIZED ARTERIAL SCREEN BLOOD FILTER 05/17/1990
K855066 COBE LABORATORIES, INC. SWANK ARTERIAL LINE BLOOD FILTER HF6000 02/26/1986
K031323 CONVERGENZA AG DBT, DYNAMIC BUBBLE TRAP 08/01/2003
K802755 DELTA MEDICAL INDUSTRIES ARTERIAL BLOOD FILTER BF-37 01/07/1981
K802602 DELTA MEDICAL INDUSTRIES L-3 PURGE LINE 11/12/1980
K810068 DELTA MEDICAL INDUSTRIES PEDIATRIC ARTERIAL BLOOD FILTER 01/22/1981
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
K902723 ELECTROMEDICS, INC. ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20 12/13/1990
K910935 ELECTROMEDICS, INC. MODIFIED PYROGEN TESTING 05/16/1991
K022071 EMBOL-X, INC. EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000 02/14/2003
K833477 EXTRACORPOREAL MEDICAL SPECIALITIES, INC. INTERSEPT 40 MICRON FILTER 12/27/1983
K833476 EXTRACORPOREAL MEDICAL SPECIALITIES, INC. INTERSEPT 40 MICRON FILTER W/TUBING 12/27/1983
K823108 EXTRACORPOREAL MEDICAL SPECIALITIES, INC. INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT 11/30/1982
K862068 GELMAN SCIENCES, INC. GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON) 08/08/1986
K851003 GISH BIOMEDICAL, INC. ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX 07/29/1985
K914791 GISH BIOMEDICAL, INC. GISH ARTERIAL FILTER 04/06/1993
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
K864262 JOHNSON & JOHNSON PROFESSIONALS, INC. ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING 01/02/1987
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
K813131 MEDICAL, INC. INTERFACE ARTERIAL BLOOD FILTER 11/27/1981
K823258 MEDICAL, INC. INTERFACE ARTERIAL BLOOD FILTER #40 11/24/1982
K862591 MEDICAL, INC. INTERFACE ARTERIAL BLOOD FILTER, MODEL 42 09/04/1986
K862609 MEDICAL, INC. INTERFACE ARTERIAL BLOOD FILTER, MODEL 44 09/04/1986
K882137 MEDTRONIC BLOOD SYSTEMS, INC. EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40 08/12/1988
K880671 MEDTRONIC BLOOD SYSTEMS, INC. MODIFIED INTERSEPT PEDIATRIC BLOOD FILTER 05/06/1988
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
K926413 MEDTRONIC VASCULAR MEDTRONIC ARTERIAL FILTER 08/24/1993
K000379 MEDTRONIC VASCULAR MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352 02/16/2000
K902518 PALL BIOMEDICAL PRODUCTS CO. LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE 10/16/1990
K853987 PALL BIOMEDICAL PRODUCTS CO. PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE 12/11/1985
K834380 PALL BIOMEDICAL PRODUCTS CO. PALL EC PLUS FILTER 08/03/1984
K834382 PALL BIOMEDICAL PRODUCTS CO. PALL EC PLUS FILTER W/FILTER SLEEVE 08/03/1984
K791748 PALL BIOMEDICAL PRODUCTS CO. ULTIPOR BLOOD FILTER EXTRA-CORPOREAL 10/02/1979
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
K811379 SHILEY, INC. SHILEY ARTERIAL FILTER 06/09/1981
K812742 SHILEY, INC. SHILEY ARTERIAL FILTER W/40 MICRON SCREE 11/02/1981
K920594 SHILEY, INC. SHILEY PERFUSION TUBING SETS 03/18/1993
K952270 SORIN BIOMEDICAL, INC. DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN 08/21/1995
K961869 SORIN BIOMEDICAL, INC. DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40 08/12/1996
K945198 SORIN BIOMEDICAL, INC. DIDECO PEDIATRIC ARTERIAL FILTERS 06/27/1995
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
K781707 SURGIKOS, INC. FILTER, ARTERIAL BLOOD W/TUBING BYPASS 10/26/1978
K790435 SURGIKOS, INC. INTERSEPT* BLOOD FILTER W/ TUBING BYPASS 03/27/1979
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
K943917 TERUMO MEDICAL CORP. CAPIOX ARTERIAL FILTER 07/25/1995
K812659 TERUMO MEDICAL CORP. TERUMO HOLLOW OXYGENATOR CIRCUIT 12/14/1981


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