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510(k) K252445

Fusion Bioline Vascular Graft by Maquet Cardiovascular, LLC — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2026
Date Received
August 4, 2025
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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  • K191947 — VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Ex (September 17, 2019)
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  • K132743 — HARVESTING CANNULA (December 3, 2013)
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  • K122612 — HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT MODEL M00202175XXXXX; M00202166XXX (September 10, 2012)

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