DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line Class II
FDA Device Classification
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 |