The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Trillium Myotherm Xp Cardioplegia Delivery System, Models 41, 41-b.
| Device ID | K011864 |
| 510k Number | K011864 |
| Device Name: | TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Contact | Marie Holm |
| Correspondent | Marie Holm MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Product Code | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-14 |
| Decision Date | 2001-07-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994947776 | K011864 | 000 |
| 20613994947769 | K011864 | 000 |