DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line Class II
FDA product code DTM covers "Filter, Blood, Cardiopulmonary Bypass, Arterial Line", a Class II medical device regulated under 21 CFR 870.4260. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DTM
- Device Class
- Class II
- Regulation Number
- 870.4260
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251744 | medtronic | Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Ar | January 16, 2026 |
| K242953 | sorin group italia | KIDS Arterial Filters | December 20, 2024 |
| K242092 | sorin group italia | MICRO Arterial Filters | November 18, 2024 |
| K231362 | transmedics | OCS Heart Leukocyte Depleting Filter | October 31, 2023 |
| K123351 | medtronic perfusion systems | AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE | March 19, 2013 |
| K122760 | medtronic | AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE | December 7, 2012 |
| K121209 | terumo cardiovascular systems corporation | TERUMO PALL AL20X ARTERIAL FILTER | May 8, 2012 |
| K112525 | parexel international | D731 MICRO 27 PH.I.S.I.O. AND D733 MICRO 40 PH.I.S.O. ARTERIAL FILTERS | September 29, 2011 |
| K100646 | medtronic | AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE | December 16, 2010 |
| K093986 | sorin group italia | AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS | January 22, 2010 |
| K093601 | sorin group italia | AF 840 PH.I.S.I.O. ARTERIAL FILTER | December 18, 2009 |
| K090518 | maquet cardiopulmonary | QUART ARTERIAL FILTER WITH SOFTLINE COATING | December 18, 2009 |
| K083747 | terumo cardiovascular systems | TERUMO PALL AL3X ARTERIAL FILTER | August 20, 2009 |
| K083834 | terumo cardiovascular systems | TERUMO PALL AL6X ARTERIAL FILTER | April 17, 2009 |
| K081054 | gish biomedical | GISH ARTERIAL FILTER WITH HA COATING | January 15, 2009 |
| K082544 | maquet cardiopulmonary | QUART ARTERIAL FILTER WITH BIOLINE COATING | October 3, 2008 |
| K072308 | sorin group italia | D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHO | September 12, 2007 |
| K071253 | medtronic vascular | AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFA | July 3, 2007 |
| K063255 | sorin group italia | D130 PH.I.S.I.O DIDECO KIDS NEONATAL ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSP | January 11, 2007 |
| K062429 | edwards lifesciences research medical | MODIFICATION TO EMBOL-X INTRA-AORTIC FILTER: X-SMALL, SMALL, MEDIUM, LARGE, X-LA | September 27, 2006 |