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 |