ClearanceBrief
Panels › Cardiovascular › Product code DTM · Class 2

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Regulation 870.4260

1510(k)s in 12 months (96 all time)
0recalls in 12 months (5 all time)
3recalls that name a 510(k)
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Top companies in DTM

Company510(k)sRecalls
Terumo Cardiovascular Systems Corp.61
Bentley Laboratories, Inc.60
Medtronic Perfusion Systems42
Sorin Group Italia S.R.L.60
American Bentley50
Pall Biomedical Products Co.50
Cobe Cardiovascular, Inc.31
Gish Biomedical, Inc.40
Medical, Inc.40
Medtronic Vascular40
Decided510(k)Device and applicantCode
Jan 16, 2026K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter
Medtronic
DTM
Dec 20, 2024K242953KIDS Arterial Filters
Sorin Group Italia S.R.L., IT
DTM
Nov 18, 2024K242092MICRO Arterial Filters
Sorin Group Italia S.R.L., IT
DTM
Oct 31, 2023K231362OCS Heart Leukocyte Depleting Filter
TransMedics, Inc.
DTM
Mar 19, 2013K123351AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
Medtronic Perfusion Systems
DTM
Dec 7, 2012K122760AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
Medtronic, Inc.
DTM
May 8, 2012K121209TERUMO PALL AL20X ARTERIAL FILTER
Terumo Cardiovascular Systems Corporation
DTM
Sep 29, 2011K112525D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS
Parexel International
DTM
Dec 16, 2010K100646AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE
Medtronic, Inc.
DTM
Jan 22, 2010K093986AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS
Sorin Group Italia S.R.L.
DTM
Dec 18, 2009K093601AF 840 PH.I.S.I.O. ARTERIAL FILTER
Sorin Group Italia S.R.L.
DTM
Dec 18, 2009K090518QUART ARTERIAL FILTER WITH SOFTLINE COATING
Maquet Cardiopulmonary, AG, DE
DTM
Aug 20, 2009K083747TERUMO PALL AL3X ARTERIAL FILTER
Terumo Cardiovascular Systems Corp.
DTM
Apr 17, 2009K083834TERUMO PALL AL6X ARTERIAL FILTER
Terumo Cardiovascular Systems Corp.
DTM
Jan 15, 2009K081054GISH ARTERIAL FILTER WITH HA COATING
Gish Biomedical, Inc.
DTM
Oct 3, 2008K082544QUART ARTERIAL FILTER WITH BIOLINE COATING
Maquet Cardiopulmonary, AG, DE
DTM
Sep 12, 2007K072308D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED
Sorin Group Italia S.R.L.
DTM
Jul 3, 2007K071253AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014
Medtronic Vascular
DTM
Jan 11, 2007K063255D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED
Sorin Group Italia S.R.L.
DTM
Sep 27, 2006K062429MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH
Edwards Lifesciences Research Medical
DTM
Jun 20, 2006K061546QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140
Maquet Cardiopulmonary, AG, DE
DTM
Oct 20, 2005K052717D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER
Dideco S.R.L.
DTM
Sep 12, 2005K052205CAPIOX AF125X ARTERIAL FILTER
Terumo Cardiovascular Systems Corp.
DTM
May 20, 2005K051232D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER
Dideco S.R.L.
DTM
May 6, 2004K041061D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS
Dideco S.P.A.
DTM
Feb 26, 2004K040184DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER
Cobe Cardiovascular, Inc.
DTM
Jan 8, 2004K033987D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS
Dideco S.P.A.
DTM
Nov 14, 2003K033468AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE
Medtronic Perfusion Systems
DTM
Nov 3, 2003K031946EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE
Edwards Lifesciences, LLC
DTM
Aug 1, 2003K032128TERUMO AL8X ARTERIAL FILTER WITH X-COATING
Terumo Cardiovascular Systems Corp.
DTM
Aug 1, 2003K031323DBT, DYNAMIC BUBBLE TRAP
Convergenza AG
DTM
Mar 31, 2003K023833GISH ARTERIAL FILTER WITH GBS COATING
Gish Biomedical, Inc.
DTM
Feb 14, 2003K022071EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000
Embol-X, Inc.
DTM
Sep 27, 2001K013084AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T
Medtronic Perfusion Systems
DTM
Jul 9, 2001K011804CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X
Terumo Cardiovascular Systems Corp.
DTM
Nov 30, 2000K002493DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER
Cobe Cardiovascular, Inc.
DTM
Sep 6, 2000K002026CAPIOX ARTERIAL FILTER
Terumo Medical Corp.
DTM
Jun 30, 2000K001787QUART ARTERIAL FILTER, MODEL HBF 140
Jostra Medizintechnik AG
DTM
Apr 27, 2000K001138AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354
Medtronic Vascular
DTM
Feb 16, 2000K000379MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352
Medtronic Vascular
DTM
Jan 13, 2000K994208AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354
Medtronic Perfusion Systems
DTM
Sep 10, 1998K982254COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD
Cobe Cardiovascular, Inc.
DTM
Sep 1, 1998K980762PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE
Pall Corp.
DTM
Aug 12, 1996K961869DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40
Sorin Biomedical, Inc.
DTM
Oct 6, 1995K952532AFFINITY ARTERIAL BLOOD FILTER
Avecor Cardiovascular, Inc.
DTM
Aug 21, 1995K952270DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN
Sorin Biomedical, Inc.
DTM
Jul 25, 1995K943917CAPIOX ARTERIAL FILTER
Terumo Medical Corp.
DTM
Jun 27, 1995K945198DIDECO PEDIATRIC ARTERIAL FILTERS
Sorin Biomedical, Inc.
DTM
Aug 24, 1993K926413MEDTRONIC ARTERIAL FILTER
Medtronic Vascular
DTM
Apr 6, 1993K914791GISH ARTERIAL FILTER
Gish Biomedical, Inc.
DTM

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