The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Myotherm Xp Cardioplegia Delivery System With Trillium Biosurface; Myotherm Xp Cardioplegia Delivery System With Trillium Biosurface With Bridge; Myotherm Xp Cardioplegia Delivery System; Myotherm Xp Cardioplegia Delivery System With Bridge.
| Device ID | K162958 |
| 510k Number | K162958 |
| Device Name: | MYOtherm XP Cardioplegia Delivery System With Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System With Trillium Biosurface With Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System With Bridge |
| Classification | Heat-exchanger, Cardiopulmonary Bypass |
| Applicant | Medtronic, Inc. 7611 Northland Drive North Minneapolis, MN 55428 |
| Contact | Harsh Dharamshi |
| Correspondent | Harsh Dharamshi Medtronic, Inc. 7611 Northland Drive North Minneapolis, MN 55428 |
| Product Code | DTR |
| CFR Regulation Number | 870.4240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2016-10-24 |
| Decision Date | 2017-02-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20763000219080 | K162958 | 000 |
| 20763000218342 | K162958 | 000 |