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510(k) K093817

GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS by Vascutek, Ltd. — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2010
Date Received
December 11, 2009
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.

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  • 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)
  • K092863 — MAXIFLO, TAPERFLO (October 8, 2009)
  • K091778 — VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS (August 31, 2009)
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  • K081560 — VASCUTEK CANNULA GRAFT, MODEL CGS2008S (February 10, 2009)

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  • 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)