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510(k) K043552

VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES by Vascutek, Ltd. — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2005
Date Received
December 27, 2004
Clearance Type
Special
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 Vascutek, Ltd.

  • K241550 — Gelweave™ Vascular Prostheses (February 27, 2025)
  • K241070 — Gelsoft™ Plus Vascular Prostheses (November 15, 2024)
  • K202703 — Vascutek Gelsoft Plus ERS Vascular Graft (April 6, 2021)
  • K200955 — Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch (July 8, 2020)
  • K162803 — Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts (July 14, 2017)
  • K162794 — Gelweave Vascular Grafts (June 30, 2017)
  • K093817 — GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS (January 7, 2010)
  • K092863 — MAXIFLO, TAPERFLO (October 8, 2009)
  • K091778 — VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS (August 31, 2009)
  • K090987 — VASCUTEK BRANCHED GELWEAVE (June 19, 2009)

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)
  • K231972 — Advanta VXT Vascular Graft, Flixene Vascular Graft (March 28, 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)