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510(k) K143398

Plato MICROCATH 27B Microcatheter by Scientia Vascular, LLC — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2015
Date Received
November 26, 2014
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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