K130280 is an FDA 510(k) clearance for the CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR. This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).
Submitted by Terumo Corporation (Elkton, US). The FDA issued a Cleared decision on March 13, 2013, 36 days after receiving the submission on February 5, 2013.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K130280 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2013 |
| Decision Date | March 13, 2013 |
| Days to Decision | 36 days |
| Submission Type | Special |
| 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 |