DTM · Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Cardiovascular · 21 CFR 870.4260 · Class 2
Overview
| Product Code | DTM |
|---|---|
| Device Name | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Regulation | 21 CFR 870.4260 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 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 | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter | Medtronic | Jan 16, 2026 | SESE |
| K242953 | KIDS Arterial Filters | Sorin Group Italia S.R.L. | Dec 20, 2024 | SESE |
| K242092 | MICRO Arterial Filters | Sorin Group Italia S.R.L. | Nov 18, 2024 | SESE |
| K231362 | OCS Heart Leukocyte Depleting Filter | TransMedics, Inc. | Oct 31, 2023 | SESE |
| K123351 | AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE | Medtronic Perfusion Systems | Mar 19, 2013 | SESE |
| K122760 | AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE | Medtronic, Inc. | Dec 7, 2012 | SESE |
| K121209 | TERUMO PALL AL20X ARTERIAL FILTER | Terumo Cardiovascular Systems Corporation | May 8, 2012 | SESE |
| K112525 | 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 | AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE | Medtronic, Inc. | Dec 16, 2010 | SESE |
| K093986 | 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 | AF 840 PH.I.S.I.O. ARTERIAL FILTER | Sorin Group Italia S.R.L. | Dec 18, 2009 | SESE |
| K090518 | QUART ARTERIAL FILTER WITH SOFTLINE COATING | Maquet Cardiopulmonary, AG | Dec 18, 2009 | SESE |
| K083747 | TERUMO PALL AL3X ARTERIAL FILTER | Terumo Cardiovascular Systems Corp. | Aug 20, 2009 | SESE |
| K083834 | TERUMO PALL AL6X ARTERIAL FILTER | Terumo Cardiovascular Systems Corp. | Apr 17, 2009 | SESE |
| K081054 | GISH ARTERIAL FILTER WITH HA COATING | Gish Biomedical, Inc. | Jan 15, 2009 | SESE |
| K082544 | QUART ARTERIAL FILTER WITH BIOLINE COATING | Maquet Cardiopulmonary, AG | Oct 3, 2008 | SESE |
| K072308 | 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 | AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 | Medtronic Vascular | Jul 3, 2007 | SESE |
| K063255 | 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 | 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
