Atlas FDA

MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300

FDA 510(k) clearance K021902 · decided 2002-08-12

Clearance details

K-number
K021902
Device name
MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
2002-06-10
Decision date
2002-08-12
Days to decision
63 days
Clearance type
Traditional
Product code
JQC
Device class
1
Regulation number
862.2050
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Minneapolis, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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Valiant Thoracic Stent Graft with the Captivia Delivery System (P100040/S073)Medtronic Vascular2025-06-12
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