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510(k) K060142

VASCUTEK GELWEAVE SIENA COLLARED ANTEFLO AND PLEXUS WITH RADIOPAQUE MARKERS by Vascutek, Ltd. — Product Code DSY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2006
Date Received
January 19, 2006
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

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  • K162803 — Gelseal Vascular Grafts, Gelsoft Vascular Grafts, Gelsoft Plus Vascular Grafts (July 14, 2017)
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  • K093817 — GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS (January 7, 2010)
  • K092863 — MAXIFLO, TAPERFLO (October 8, 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)