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510(k) K213845

HeRO Graft by Merit Medical Systems, Inc. — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2022
Date Received
December 9, 2021
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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