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FDA 510(k)

Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach

K-Number: K172557 · 2017-11-20

ApplicantWilliam Cook Europe Aps
Decision Date2017-11-20
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach is a medical device manufactured by William Cook Europe Aps. It received FDA 510(k) clearance on 2017-11-20 under approval number K172557. The device is classified under product code DTK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach?

Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach is a medical device that received FDA 510(k) clearance on 2017-11-20. It is manufactured by William Cook Europe Aps. The 510(k) number is K172557.

When was Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach approved by the FDA?

Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach received FDA 510(k) clearance on 2017-11-20, under approval number K172557.

What company makes Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach?

Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach is manufactured by William Cook Europe Aps.

What is the FDA product code for Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach?

The FDA product code for Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach is DTK.

Related Clinical Trials

NCT03776799 BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery ACTIVE_NOT_RECRUITING NCT07562971 Focused Ultrasound Blood-Brain Barrier Opening in Pontine Diffuse Midline Glioma to Enhance Temozolomide Therapy: Pilot Feasibility Study (FIDES) NOT_YET_RECRUITING NCT05881798 Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study RECRUITING NCT07019662 Comparing a Suture-based System for the Removal of Arterial and Veinous ECMO Cannulas to the Standard Approach RECRUITING

Other Devices by William Cook Europe Aps

K171513Lunderquist Extra Stiff Wire Guide K172584Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach K171712Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach K161813Frova Intubating Introducer K211875Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach K211874Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach

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Related Devices (Code: DTK)

K161218Gianturco-Roehm Bird’s Nest Vena Cava FilterCook Incorporated K160866Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery KitC.R. Bard, Inc. K152765VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEMB. Braun Interventional Systems, Inc. K172584Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps K163699ALN Optional Vena Cava Filter - Femoral Approach, ALN Optional Vena Cava Filter - Jugular Approach, ALN Optional Vena Cava Filter - Brachial Approach, ALN Optional Vena Cava Filter - Femoral Approach with HookAln Implants Chirurgicaux K171712Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein ApproachWilliam Cook Europe Aps

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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