K153376 is an FDA 510(k) clearance for the Advanced Perfusion System 1. This device is classified as a Console, Heart-lung Machine, Cardiopulmonary Bypass (Class II - Special Controls, product code DTQ).
Submitted by Terumo Cardiovascular Systems Corporation (Ann Arbor, US). The FDA issued a Cleared decision on December 16, 2015, 23 days after receiving the submission on November 23, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4220.
| 510(k) Number | K153376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 23, 2015 |
| Decision Date | December 16, 2015 |
| Days to Decision | 23 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTQ — Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4220 |