Product Code: DTM FDA class 2 21 CFR 870.4260

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

Cardiovascular

The Arterial Line Blood Filter for Cardiopulmonary Bypass is a life-sustaining cardiovascular device placed in the arterial return line of a bypass circuit to remove air, particulate debris, and microemboli from blood before it is returned to the patient during open-heart surgery. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DTM and it is regulated under 21 CFR 870.4260 within the Cardiovascular medical specialty. This device is designated as life-sustaining or life-supporting.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DTM
Device Class: FDA class 2
Regulation Number: 870.4260
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 96 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251744	Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter	Jan 16, 2026	Substantially Equivalent	Medtronic
K242953	KIDS Arterial Filters	Dec 20, 2024	Substantially Equivalent	Sorin Group Italia S.R.L.
K242092	MICRO Arterial Filters	Nov 18, 2024	Substantially Equivalent	Sorin Group Italia S.R.L.
K231362	OCS Heart Leukocyte Depleting Filter	Oct 31, 2023	Substantially Equivalent	TransMedics, Inc.
K123351	AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE	Mar 19, 2013	Substantially Equivalent	Medtronic Perfusion Systems
K122760	AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE	Dec 07, 2012	Substantially Equivalent	Medtronic, Inc.
K121209	TERUMO PALL AL20X ARTERIAL FILTER	May 08, 2012	Substantially Equivalent	Terumo Cardiovascular Systems Corporation
K112525	D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS	Sep 29, 2011	Substantially Equivalent	Parexel International
K100646	AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE	Dec 16, 2010	Substantially Equivalent	Medtronic, Inc.
K093986	AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS	Jan 22, 2010	Substantially Equivalent	Sorin Group Italia S.R.L.
K093601	AF 840 PH.I.S.I.O. ARTERIAL FILTER	Dec 18, 2009	Substantially Equivalent	Sorin Group Italia S.R.L.
K090518	QUART ARTERIAL FILTER WITH SOFTLINE COATING	Dec 18, 2009	Substantially Equivalent	Maquet Cardiopulmonary, AG
K083747	TERUMO PALL AL3X ARTERIAL FILTER	Aug 20, 2009	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K083834	TERUMO PALL AL6X ARTERIAL FILTER	Apr 17, 2009	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K081054	GISH ARTERIAL FILTER WITH HA COATING	Jan 15, 2009	Substantially Equivalent	Gish Biomedical, Inc.
K082544	QUART ARTERIAL FILTER WITH BIOLINE COATING	Oct 03, 2008	Substantially Equivalent	Maquet Cardiopulmonary, AG
K072308	D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED	Sep 12, 2007	Substantially Equivalent	Sorin Group Italia S.R.L.
K071253	AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014	Jul 03, 2007	Substantially Equivalent	Medtronic Vascular
K063255	D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED	Jan 11, 2007	Substantially Equivalent	Sorin Group Italia S.R.L.
K062429	MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH	Sep 27, 2006	Substantially Equivalent	Edwards Lifesciences Research Medical
K061546	QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140	Jun 20, 2006	Substantially Equivalent	Maquet Cardiopulmonary, AG
K052717	D732 MICRO 27 PH.I.S.I.O. ADULT ARTERIAL FILTER	Oct 20, 2005	Substantially Equivalent	Dideco S.R.L.
K052205	CAPIOX AF125X ARTERIAL FILTER	Sep 12, 2005	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K051232	D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER	May 20, 2005	Substantially Equivalent	Dideco S.R.L.
K041061	D731 MICRO 20 AND D733 MICRO 40 PEDIATRIC ARTERIAL FILTERS	May 06, 2004	Substantially Equivalent	Dideco S.P.A.
K040184	DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER	Feb 26, 2004	Substantially Equivalent	Cobe Cardiovascular, Inc.
K033987	D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS	Jan 08, 2004	Substantially Equivalent	Dideco S.P.A.
K033468	AFFINITY 20U ARTERIAL FILTER WITH TRILLIUM BIOSURFACE	Nov 14, 2003	Substantially Equivalent	Medtronic Perfusion Systems
K031946	EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE	Nov 03, 2003	Substantially Equivalent	Edwards Lifesciences, LLC
K032128	TERUMO AL8X ARTERIAL FILTER WITH X-COATING	Aug 01, 2003	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K031323	DBT, DYNAMIC BUBBLE TRAP	Aug 01, 2003	Substantially Equivalent	Convergenza AG
K023833	GISH ARTERIAL FILTER WITH GBS COATING	Mar 31, 2003	Substantially Equivalent	Gish Biomedical, Inc.
K022071	EMBOL-X AORTIC FILTERS,ETRA-SMALL,SMALL,MEDIUM,LARGE,EXTRA LARGE,MODELS CF26000.CF29000,CF32000,CF35000,CF4000	Feb 14, 2003	Substantially Equivalent	Embol-X, Inc.
K013084	AFFINITY 38 MICON ARTERIAL FILTER WITH TRILLIUM BIOPASSIVE SURFACE, MODEL 351T	Sep 27, 2001	Substantially Equivalent	Medtronic Perfusion Systems
K011804	CAPIOX ARTERIAL FILTER WITH X-COATING, PRODUCT CODE CX*AFO2X	Jul 09, 2001	Substantially Equivalent	Terumo Cardiovascular Systems Corp.
K002493	DIDECO MICRO 40 PH.I.S.I.O (PHOSPHORYLCHOLINE INSERT SURFACE IN OXGENATION) NEWBORN/INFANT ARTERIAL FILTER	Nov 30, 2000	Substantially Equivalent	Cobe Cardiovascular, Inc.
K002026	CAPIOX ARTERIAL FILTER	Sep 06, 2000	Substantially Equivalent	Terumo Medical Corp.
K001787	QUART ARTERIAL FILTER, MODEL HBF 140	Jun 30, 2000	Substantially Equivalent	Jostra Medizintechnik AG
K001138	AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354	Apr 27, 2000	Substantially Equivalent	Medtronic Vascular
K000379	MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352	Feb 16, 2000	Substantially Equivalent	Medtronic Vascular
K994208	AFFINITY 20 MICRON ARTERIAL BLOOD FILTER, MODEL 353/354	Jan 13, 2000	Substantially Equivalent	Medtronic Perfusion Systems
K982254	COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD	Sep 10, 1998	Substantially Equivalent	Cobe Cardiovascular, Inc.
K980762	PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE	Sep 01, 1998	Substantially Equivalent	Pall Corp.
K961869	DIDECO NEWBORN/INFANT ARTERIAL FILTERS: D735 MICRO 20 AND D736 MICRO 40	Aug 12, 1996	Substantially Equivalent	Sorin Biomedical, Inc.
K952532	AFFINITY ARTERIAL BLOOD FILTER	Oct 06, 1995	Substantially Equivalent	Avecor Cardiovascular, Inc.
K952270	DIDECO ADULT ARTERIAL FILTERS D732 MICRO 20 W/20, D734 MICRO 40 W/40 MICRON SCREEN	Aug 21, 1995	Substantially Equivalent	Sorin Biomedical, Inc.
K943917	CAPIOX ARTERIAL FILTER	Jul 25, 1995	Substantially Equivalent	Terumo Medical Corp.
K945198	DIDECO PEDIATRIC ARTERIAL FILTERS	Jun 27, 1995	Substantially Equivalent	Sorin Biomedical, Inc.
K926413	MEDTRONIC ARTERIAL FILTER	Aug 24, 1993	Substantially Equivalent	Medtronic Vascular
K914791	GISH ARTERIAL FILTER	Apr 06, 1993	Substantially Equivalent	Gish Biomedical, Inc.
K920594	SHILEY PERFUSION TUBING SETS	Mar 18, 1993	Substantially Equivalent	Shiley, Inc.
K910935	MODIFIED PYROGEN TESTING	May 16, 1991	Substantially Equivalent	Electromedics, Inc.
K902723	ARTERIAL BLOOD FILTER ELECTRO. AIR* STAR 40 AND 20	Dec 13, 1990	Substantially Equivalent	Electromedics, Inc.
K902518	LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE	Oct 16, 1990	Substantially Equivalent	Pall Biomedical Products Co.
K900758	HEPARINIZED ARTERIAL SCREEN BLOOD FILTER	May 17, 1990	Substantially Equivalent	Cobe Laboratories, Inc.
K892387	MODIFIED GELMAN ARTERIAL FILTER	Jun 22, 1989	Substantially Equivalent	Gelman Sciences, Inc.
K882137	EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40	Aug 12, 1988	Substantially Equivalent	Medtronic Blood Systems, Inc.
K873316	BUBBLE TRAP-FILTER CAT. NO B180F37	Jul 14, 1988	Substantially Equivalent	American Omni Medical, Inc.
K880671	MODIFIED INTERSEPT PEDIATRIC BLOOD FILTER	May 06, 1988	Substantially Equivalent	Medtronic Blood Systems, Inc.
K875080	AIR VENT LINE CAT. NO. AVL-36	Feb 29, 1988	Substantially Equivalent	American Omni Medical, Inc.
K864262	ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING	Jan 02, 1987	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K862609	INTERFACE ARTERIAL BLOOD FILTER, MODEL 44	Sep 04, 1986	Substantially Equivalent	Medical, Inc.
K862591	INTERFACE ARTERIAL BLOOD FILTER, MODEL 42	Sep 04, 1986	Substantially Equivalent	Medical, Inc.
K862068	GELMAN ARTERIAL FILTER (43, 33 AND 21 MICRON)	Aug 08, 1986	Substantially Equivalent	Gelman Sciences, Inc.
K855066	SWANK ARTERIAL LINE BLOOD FILTER HF6000	Feb 26, 1986	Substantially Equivalent	Cobe Laboratories, Inc.
K853987	PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE	Dec 11, 1985	Substantially Equivalent	Pall Biomedical Products Co.
K851003	ARTERIAL FILTER AFS-XX /FILTER HOLDER AFS-HXX	Jul 29, 1985	Substantially Equivalent	Gish Biomedical, Inc.
K842813	HEPARIN COATED ARTERIAL BLOOD FILTERS	Jan 08, 1985	Substantially Equivalent	American Bentley
K834382	PALL EC PLUS FILTER W/FILTER SLEEVE	Aug 03, 1984	Substantially Equivalent	Pall Biomedical Products Co.
K834380	PALL EC PLUS FILTER	Aug 03, 1984	Substantially Equivalent	Pall Biomedical Products Co.
K840612	PEDIATRIC ARTERIAL BLOOD FILTER	Apr 17, 1984	Substantially Equivalent	American Bentley
K831507	LOW TRAUMA ARTERIAL FILTER H-640	Dec 29, 1983	Substantially Equivalent	C.R. Bard, Inc.
K833477	INTERSEPT 40 MICRON FILTER	Dec 27, 1983	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K833476	INTERSEPT 40 MICRON FILTER W/TUBING	Dec 27, 1983	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K833048	PURGES LINES, PL-45 & PL-33	Oct 20, 1983	Substantially Equivalent	American Bentley
K830132	ARTERIAL BLOOD FILTER AF-1040-AF-1040BL	Jan 28, 1983	Substantially Equivalent	American Bentley
K830131	ARTERIAL BLOOD FILTER AF-1025-AF-1025BL	Jan 28, 1983	Substantially Equivalent	American Bentley
K823108	INTERSEPT PEDIACTRIC EXTRACORPOREAL FILT	Nov 30, 1982	Substantially Equivalent	Extracorporeal Medical Specialities, Inc.
K823258	INTERFACE ARTERIAL BLOOD FILTER #40	Nov 24, 1982	Substantially Equivalent	Medical, Inc.
K820044	ARTERIAL BLOOD FILTER, #AF-1025	Jun 29, 1982	Substantially Equivalent	Bentley Laboratories, Inc.
K820679	PEDIATRIC ARTERIAL BLOOD FILTER #AF-540	Jun 17, 1982	Substantially Equivalent	Bentley Laboratories, Inc.
K820343	ARTERIAL BLOOD FILTER MODEL #AF-1040	Jun 17, 1982	Substantially Equivalent	Bentley Laboratories, Inc.
K820472	WILLIAM HARVEY H-625 ARTERIAL FILTER	Mar 15, 1982	Substantially Equivalent	C.R. Bard, Inc.
K820045	CARDIOVASCULAR DEVICES	Jan 29, 1982	Substantially Equivalent	Bentley Laboratories, Inc.
K812659	TERUMO HOLLOW OXYGENATOR CIRCUIT	Dec 14, 1981	Substantially Equivalent	Terumo Medical Corp.
K813131	INTERFACE ARTERIAL BLOOD FILTER	Nov 27, 1981	Substantially Equivalent	Medical, Inc.
K812742	SHILEY ARTERIAL FILTER W/40 MICRON SCREE	Nov 02, 1981	Substantially Equivalent	Shiley, Inc.
K811379	SHILEY ARTERIAL FILTER	Jun 09, 1981	Substantially Equivalent	Shiley, Inc.
K810068	PEDIATRIC ARTERIAL BLOOD FILTER	Jan 22, 1981	Substantially Equivalent	Delta Medical Industries
K802755	ARTERIAL BLOOD FILTER BF-37	Jan 07, 1981	Substantially Equivalent	Delta Medical Industries
K802602	L-3 PURGE LINE	Nov 12, 1980	Substantially Equivalent	Delta Medical Industries
K801147	PEDIATRIC ARTERIAL BLOOD FILTER #AF-5	Jun 04, 1980	Substantially Equivalent	Bentley Laboratories, Inc.
K792450	ARTERIAL BLOOD FILTER, MODEL AF-10	Dec 19, 1979	Substantially Equivalent	Bentley Laboratories, Inc.
K791748	ULTIPOR BLOOD FILTER EXTRA-CORPOREAL	Oct 02, 1979	Substantially Equivalent	Pall Biomedical Products Co.
K790435	INTERSEPT* BLOOD FILTER W/ TUBING BYPASS	Mar 27, 1979	Substantially Equivalent	Surgikos, Inc.
K781707	FILTER, ARTERIAL BLOOD W/TUBING BYPASS	Oct 26, 1978	Substantially Equivalent	Surgikos, Inc.