The following data is part of a premarket notification filed by Medtronic Perfusion Systems with the FDA for Magellan Ratio Dispenser Kit.
| Device ID | K041830 |
| 510k Number | K041830 |
| Device Name: | MAGELLAN RATIO DISPENSER KIT |
| Classification | Syringe, Piston |
| Applicant | MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
| Contact | Bruce Backlund |
| Correspondent | Bruce Backlund MEDTRONIC PERFUSION SYSTEMS 7611 NORTHLAND DR. Minneapolis, MN 55038 |
| Product Code | FMF |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-07 |
| Decision Date | 2004-09-29 |
| Summary: | summary |