510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K021902Substantially Equivalent

Magellan Autologus Platelet Separator, Mag100, Magellan Autologous Platelet Separator Deisposable Kit, Mkt300

Medtronic, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K021902 is the FDA 510(k) clearance record for MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300, a class I device, cleared for Medtronic Vascular on under FDA product code JQC (Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K021902.

Clearance record

Decision date
Received
(63 days to decision)
Product code
JQC Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Medtronic Vascular 7611 Northland Dr., Minneapolis MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JQC

Trailing 12 months

FDA records hold no clearances under product code JQC in the trailing twelve months.

FDA records show no clearances under product code JQC in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JQC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260