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510(k) K070323

TEMPORARY LIMB SALVAGE SHUNT by Vascutek, Ltd. — Product Code DXC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 2007
Date Received
February 2, 2007
Clearance Type
Traditional
Expedited Review
Yes
Third Party Review
No

Device Classification

Device Name
Clamp, Vascular
Device Class
Class II
Regulation Number
870.4450
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)
  • K091778 — VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS (August 31, 2009)
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  • K222182 — Radial Artery Compression Tourniquets (January 4, 2023)
  • K221843 — GEM Biover Microvascular Clamps (September 14, 2022)
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