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510(k) K131778

FUSION VASCULAR GRAFT AND FUSION BIOLINE VASCULAR GRAFT by Maquet Cardiovascular, LLC — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2013
Date Received
June 17, 2013
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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