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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
510(k) Number K021902
Device Name MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300
Applicant
Medtronic Vascular
7611 Northland Dr.
Minneapolis,  MN  55428
Applicant Contact LUCY TAN
Correspondent
Medtronic Vascular
7611 Northland Dr.
Minneapolis,  MN  55428
Correspondent Contact LUCY TAN
Regulation Number862.2050
Classification Product Code
JQC  
Subsequent Product Code
FMF  
Date Received06/10/2002
Decision Date 08/12/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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