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510(k) K170406

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2017
Date Received
February 10, 2017
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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