The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Trillium Affinity Nt Cardiotomy Venous Reservoir, Models 540t, 541tt.
Device ID | K021287 |
510k Number | K021287 |
Device Name: | TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT |
Classification | Reservoir, Blood, Cardiopulmonary Bypass |
Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
Contact | Preeti Jain |
Correspondent | Preeti Jain MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
Product Code | DTN |
CFR Regulation Number | 870.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-04-23 |
Decision Date | 2002-05-07 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20721902648759 | K021287 | 000 |