K081054 is an FDA 510(k) clearance for the GISH ARTERIAL FILTER WITH HA COATING. This device is classified as a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II - Special Controls, product code DTM).
Submitted by Gish Biomedical, Inc. (Houston, US). The FDA issued a Cleared decision on January 15, 2009, 276 days after receiving the submission on April 14, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4260.
| 510(k) Number | K081054 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 2008 |
| Decision Date | January 15, 2009 |
| Days to Decision | 276 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 |