The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Trillium Tri-optic Measurement Cell, Model Tmc 25t, Tmc38 T, Tmc 50t.
| Device ID | K012743 |
| 510k Number | K012743 |
| Device Name: | TRILLIUM TRI-OPTIC MEASUREMENT CELL, MODEL TMC 25T, TMC38 T, TMC 50T |
| Classification | Monitor, Blood-gas, On-line, Cardiopulmonary Bypass |
| Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
| Contact | Marie Holm |
| Correspondent | Marie Holm MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
| Product Code | DRY |
| CFR Regulation Number | 870.4330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-16 |
| Decision Date | 2001-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20681490009830 | K012743 | 000 |
| 20681490009823 | K012743 | 000 |
| 20681490009816 | K012743 | 000 |
| 20721902358948 | K012743 | 000 |
| 20721902358917 | K012743 | 000 |