FDA 510(k)

Gianturco-Roehm Birds Nest Vena Cava Filter

K-Number: K161218 · 2016-07-22

Decision Date2016-07-22

Product CodeDTK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Gianturco-Roehm Birds Nest Vena Cava Filter is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2016-07-22 under approval number K161218. 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 Gianturco-Roehm Birds Nest Vena Cava Filter?

Gianturco-Roehm Birds Nest Vena Cava Filter is a medical device that received FDA 510(k) clearance on 2016-07-22. It is manufactured by Cook Incorporated. The 510(k) number is K161218.

When was Gianturco-Roehm Birds Nest Vena Cava Filter approved by the FDA?

Gianturco-Roehm Birds Nest Vena Cava Filter received FDA 510(k) clearance on 2016-07-22, under approval number K161218.

What company makes Gianturco-Roehm Birds Nest Vena Cava Filter?

Gianturco-Roehm Birds Nest Vena Cava Filter is manufactured by Cook Incorporated.

What is the FDA product code for Gianturco-Roehm Birds Nest Vena Cava Filter?

The FDA product code for Gianturco-Roehm Birds Nest Vena Cava Filter is DTK.

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Related Devices (Code: DTK)

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 K172557Gunther 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 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.