K926413 is an FDA 510(k) clearance for the MEDTRONIC ARTERIAL FILTER. This device is classified as a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II - Special Controls, product code DTM).
Submitted by Medtronic Vascular (Anaheim, US). The FDA issued a Cleared decision on August 24, 1993, 244 days after receiving the submission on December 23, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4260.
| 510(k) Number | K926413 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 1992 |
| Decision Date | August 24, 1993 |
| Days to Decision | 244 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 |