K153295 is an FDA 510(k) clearance for the TandemLung Oxygenator. This device is classified as a Oxygenator, Cardiopulmonary Bypass (Class II - Special Controls, product code DTZ).
Submitted by Cardiacassist, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on February 26, 2016, 105 days after receiving the submission on November 13, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4350.
| 510(k) Number | K153295 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2015 |
| Decision Date | February 26, 2016 |
| Days to Decision | 105 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 |