The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Trillium Bio Disposable Blood Flow Probe (models Dp38t & Fp38p).
| Device ID | K012747 |
| 510k Number | K012747 |
| Device Name: | TRILLIUM BIO DISPOSABLE BLOOD FLOW PROBE (MODELS DP38T & FP38P) |
| Classification | Probe, Blood-flow, Extravascular |
| 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 | DPT |
| CFR Regulation Number | 870.2120 [🔎] |
| 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 |
|---|---|---|
| 20721902325780 | K012747 | 000 |
| 20721902325742 | K012747 | 000 |