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510(k) K090140

GUNTHER TULIP VENA CAVA FILTER, COOK CELECT VENA CAVA FILTER by William Cook Europe Aps — Product Code DTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2009
Date Received
January 21, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Intravascular, Cardiovascular
Device Class
Class II
Regulation Number
870.3375
Review Panel
CV
Submission Type

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  • K220137 — Lunderquist Extra Stiff Wire Guide (February 17, 2022)
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  • K171513 — Lunderquist Extra Stiff Wire Guide (December 7, 2017)
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  • K172584 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena (November 20, 2017)
  • K171712 — Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect (August 7, 2017)

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  • K240257 — Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit (February 29, 2024)
  • K233680 — Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM- (January 18, 2024)
  • K211875 — Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect (July 28, 2021)
  • K211874 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena (July 28, 2021)
  • K181202 — Sentry IVC Filter (June 6, 2018)
  • K173236 — Sentry IVC Filter (February 22, 2018)
  • K172557 — Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena (November 20, 2017)