K081947 is an FDA 510(k) clearance for the GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR 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. (Houston, US). The FDA issued a Cleared decision on February 4, 2009, 211 days after receiving the submission on July 8, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4400.
| 510(k) Number | K081947 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 08, 2008 |
| Decision Date | February 04, 2009 |
| Days to Decision | 211 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 |