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510(k) K192267

ILUMIEN System with AptiVue Software version D.3 by Abbott Medical — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2019
Date Received
August 21, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

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