K153213 is an FDA 510(k) clearance for the Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir. This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).
Submitted by Terumo Cardiovascular Systems Corporation (Elkton, US). The FDA issued a Cleared decision on December 3, 2015, 28 days after receiving the submission on November 5, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K153213 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 2015 |
| Decision Date | December 03, 2015 |
| Days to Decision | 28 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 |