K162958 is an FDA 510(k) clearance for the MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface. This device is classified as a Heat-exchanger, Cardiopulmonary Bypass (Class II - Special Controls, product code DTR).
Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 1, 2017, 100 days after receiving the submission on October 24, 2016.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4240.
| 510(k) Number | K162958 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 24, 2016 |
| Decision Date | February 01, 2017 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTR — Heat-exchanger, Cardiopulmonary Bypass |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4240 |