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510(k) K130142

FLIXENE IFG VASCULAR GRAFT by Atrium Medical Corporation — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2013
Date Received
January 22, 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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  • K240083 — GORE® PROPATEN® Vascular Graft (March 1, 2024)
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  • K232312 — GORE® PROPATEN® Vascular Graft (January 9, 2024)
  • K233551 — GORE® ACUSEAL Vascular Graft (December 19, 2023)
  • K231505 — GORE® ACUSEAL Vascular Graft (June 23, 2023)
  • K213845 — HeRO Graft (August 15, 2022)