K122760 is an FDA 510(k) clearance for the AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE. This device is classified as a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II - Special Controls, product code DTM).
Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 7, 2012, 88 days after receiving the submission on September 10, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4260.
| 510(k) Number | K122760 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2012 |
| Decision Date | December 07, 2012 |
| Days to Decision | 88 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 |