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510(k) K121734

PLATO MICROCATH 27 MICROCATHETER by Scientia Vascular, LLC — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2012
Date Received
June 13, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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