Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart E — Cardiovascular Surgical Devices](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices) → [21 CFR 870.4260](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4260) → DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line # DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line _Cardiovascular · 21 CFR 870.4260 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM ## Overview - **Product Code:** DTM - **Device Name:** Filter, Blood, Cardiopulmonary Bypass, Arterial Line - **Regulation:** [21 CFR 870.4260](/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/870.4260) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **Life-sustaining:** yes ## Identification A cardiopulmonary bypass arterial line blood filter is a device used as part of a gas exchange (oxygenator) system to filter nonbiologic particles and emboli (blood clots or pieces of foreign material flowing in the bloodstream which will obstruct circulation by blocking a vessel) out of the blood. It is used in the arterial return line. ## Classification Rationale Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.” ## Special Controls *Classification.* Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Arterial Line Blood Filter 510(k) Submissions.” ## Recent Cleared Devices (20 of 96) Showing 20 most recent of 96 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K251744](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K251744.md) | Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood Filter | Medtronic | Jan 16, 2026 | SESE | | [K242953](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K242953.md) | KIDS Arterial Filters | Sorin Group Italia S.R.L. | Dec 20, 2024 | SESE | | [K242092](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K242092.md) | MICRO Arterial Filters | Sorin Group Italia S.R.L. | Nov 18, 2024 | SESE | | [K231362](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K231362.md) | OCS Heart Leukocyte Depleting Filter | TransMedics, Inc. | Oct 31, 2023 | SESE | | [K123351](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K123351.md) | AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE | Medtronic Perfusion Systems | Mar 19, 2013 | SESE | | [K122760](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K122760.md) | AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE | Medtronic, Inc. | Dec 7, 2012 | SESE | | [K121209](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K121209.md) | TERUMO PALL AL20X ARTERIAL FILTER | Terumo Cardiovascular Systems Corporation | May 8, 2012 | SESE | | [K112525](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K112525.md) | D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS | Parexel International | Sep 29, 2011 | SESE | | [K100646](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K100646.md) | AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE | Medtronic, Inc. | Dec 16, 2010 | SESE | | [K093986](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K093986.md) | AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS | Sorin Group Italia S.R.L. | Jan 22, 2010 | SESE | | [K093601](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K093601.md) | AF 840 PH.I.S.I.O. ARTERIAL FILTER | Sorin Group Italia S.R.L. | Dec 18, 2009 | SESE | | [K090518](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K090518.md) | QUART ARTERIAL FILTER WITH SOFTLINE COATING | Maquet Cardiopulmonary, AG | Dec 18, 2009 | SESE | | [K083747](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K083747.md) | TERUMO PALL AL3X ARTERIAL FILTER | Terumo Cardiovascular Systems Corp. | Aug 20, 2009 | SESE | | [K083834](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K083834.md) | TERUMO PALL AL6X ARTERIAL FILTER | Terumo Cardiovascular Systems Corp. | Apr 17, 2009 | SESE | | [K081054](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K081054.md) | GISH ARTERIAL FILTER WITH HA COATING | Gish Biomedical, Inc. | Jan 15, 2009 | SESE | | [K082544](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K082544.md) | QUART ARTERIAL FILTER WITH BIOLINE COATING | Maquet Cardiopulmonary, AG | Oct 3, 2008 | SESE | | [K072308](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K072308.md) | D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED | Sorin Group Italia S.R.L. | Sep 12, 2007 | SESE | | [K071253](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K071253.md) | AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 | Medtronic Vascular | Jul 3, 2007 | SESE | | [K063255](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K063255.md) | D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYLCHOLINE COATED | Sorin Group Italia S.R.L. | Jan 11, 2007 | SESE | | [K062429](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM/K062429.md) | MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LARGE WITH HEPARIN COATED MESH | Edwards Lifesciences Research Medical | Sep 27, 2006 | SESE | ## Top Applicants - Sorin Group Italia S.R.L. — 6 clearances - Bentley Laboratories, Inc. — 6 clearances - Terumo Cardiovascular Systems Corp. — 5 clearances - Pall Biomedical Products Co. — 5 clearances - American Bentley — 5 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM](https://fda.innolitics.com/submissions/CV/subpart-e%E2%80%94cardiovascular-surgical-devices/DTM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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