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510(k) K153523

FUSION Vascular Graft by Maquet Cardiovascular, LLC — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 16, 2016
Date Received
December 9, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class
Class II
Regulation Number
870.3450
Review Panel
CV
Submission Type

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