K982254 is an FDA 510(k) clearance for the COBE SENTRY SMARXT 43 MICRON ARTERIAL FILTER WITH PRIMEGARD. This device is classified as a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II - Special Controls, product code DTM).
Submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on September 10, 1998, 76 days after receiving the submission on June 26, 1998.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4260.
| 510(k) Number | K982254 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 1998 |
| Decision Date | September 10, 1998 |
| Days to Decision | 76 days |
| Submission Type | Abbreviated |
| 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 |