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 |