K021902 is an FDA 510(k) clearance for the MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300. This device is classified as a Centrifuges (micro, Ultra, Refrigerated) For Clinical Use (Class I - General Controls, product code JQC).
Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on August 12, 2002, 63 days after receiving the submission on June 10, 2002.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 862.2050.
| 510(k) Number | K021902 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2002 |
| Decision Date | August 12, 2002 |
| Days to Decision | 63 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JQC — Centrifuges (micro, Ultra, Refrigerated) For Clinical Use |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.2050 |