K051606 is an FDA 510(k) clearance for the GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS 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 August 12, 2005, 57 days after receiving the submission on June 16, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4400.
| 510(k) Number | K051606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2005 |
| Decision Date | August 12, 2005 |
| Days to Decision | 57 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 |