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 |