K093986 is an FDA 510(k) clearance for the AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS. This device is classified as a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II - Special Controls, product code DTM).
Submitted by Sorin Group Italia S.R.L. (Waltham, US). The FDA issued a Cleared decision on January 22, 2010, 29 days after receiving the submission on December 24, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4260.
| 510(k) Number | K093986 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 24, 2009 |
| Decision Date | January 22, 2010 |
| Days to Decision | 29 days |
| Submission Type | Special |
| 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 |