The following data is part of a premarket notification filed by Medtronic Vascular with the FDA for Magellan Autologus Platelet Separator, Mag100, Magellan Autologous Platelet Separator Deisposable Kit, Mkt300.
| Device ID | K021902 |
| 510k Number | K021902 |
| Device Name: | MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 |
| Classification | Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Applicant | MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Contact | Lucy Tan |
| Correspondent | Lucy Tan MEDTRONIC VASCULAR 7611 NORTHLAND DR. Minneapolis, MN 55428 |
| Product Code | JQC |
| CFR Regulation Number | 862.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-10 |
| Decision Date | 2002-08-12 |
| Summary: | summary |