The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Trillium Biopump Plus, Model Bpx80t.
| Device ID | K050109 |
| 510k Number | K050109 |
| Device Name: | TRILLIUM BIOPUMP PLUS, MODEL BPX80T |
| Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| 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 | KFM |
| CFR Regulation Number | 870.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-01-18 |
| Decision Date | 2005-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994462503 | K050109 | 000 |
| 00643169630628 | K050109 | 000 |