The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Myotherm Xp Cardioplegia Delivery System With Cortiva Bioactive Surface, Myotherm Xp Cardioplegia Delivery System With Cortiva Bioactive Surface (bridge System).
| Device ID | K162774 |
| 510k Number | K162774 |
| Device Name: | MYOtherm XP Cardioplegia Delivery System With Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System With Cortiva BioActive Surface (Bridge System) |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
| Contact | Harsh Dharamshi |
| Correspondent | Harsh Dharamshi Medtronic, Inc. 8200 Coral Sea Street NE Mounts View, MN 55112 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-10-03 |
| Decision Date | 2017-02-10 |
| Summary: | summary |