K080708 is an FDA 510(k) clearance for the VISION HOLLOW FIBER OXYGENATOR WITH HA COATING. This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).
Submitted by Gish Biomedical, Inc. (Houston, US). The FDA issued a Cleared decision on February 2, 2009, 327 days after receiving the submission on March 12, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K080708 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 12, 2008 |
| Decision Date | February 02, 2009 |
| Days to Decision | 327 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTZ — Oxygenator, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4350 |