K082082 is an FDA 510(k) clearance for the GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING. This device is classified as a Reservoir, Blood, Cardiopulmonary Bypass (Class II - Special Controls, product code DTN).
Submitted by Gish Biomedical, Inc. (Rancho Santa Margarita, US). The FDA issued a Cleared decision on February 4, 2009, 196 days after receiving the submission on July 23, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4400.
| 510(k) Number | K082082 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2008 |
| Decision Date | February 04, 2009 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTN — Reservoir, Blood, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4400 |