K123351 is an FDA 510(k) clearance for the AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE. This device is classified as a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II - Special Controls, product code DTM).
Submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on March 19, 2013, 139 days after receiving the submission on October 31, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4260.
| 510(k) Number | K123351 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 2012 |
| Decision Date | March 19, 2013 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4260 |