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510(k) K231972

Advanta VXT Vascular Graft, Flixene Vascular Graft by Atrium Medical Corporation — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 28, 2024
Date Received
July 3, 2023
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

Other clearances by Atrium Medical Corporation

  • K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suc (September 3, 2021)
  • K151386 — C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic (October 22, 2015)
  • K151437 — ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug (August 27, 2015)
  • K130142 — FLIXENE IFG VASCULAR GRAFT (March 15, 2013)
  • K110110 — ATRIUM CENTRILFX MESH (February 15, 2011)

Other clearances for product code DSY

  • K252277 — Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) (October 20, 2025)
  • K241550 — Gelweave™ Vascular Prostheses (February 27, 2025)
  • K241070 — Gelsoft™ Plus Vascular Prostheses (November 15, 2024)
  • K240083 — GORE® PROPATEN® Vascular Graft (March 1, 2024)
  • K233783 — exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts (January 17, 2024)
  • 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)
  • K221628 — exGraft, exGraft Carbon (August 4, 2022)