K081838 is an FDA 510(k) clearance for the GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING. This device is classified as a Heat-exchanger, Cardiopulmonary Bypass (Class II - Special Controls, product code DTR).
Submitted by Gish Biomedical, Inc. (Rancho Santa Margarita, US). The FDA issued a Cleared decision on January 26, 2009, 210 days after receiving the submission on June 30, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4240.
| 510(k) Number | K081838 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2008 |
| Decision Date | January 26, 2009 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTR — Heat-exchanger, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4240 |