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FDA 510(k)

Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit

K-Number: K240257 · 2024-02-29

ApplicantBd
Decision Date2024-02-29
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit is a medical device manufactured by Bd. It received FDA 510(k) clearance on 2024-02-29 under approval number K240257. 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 Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit?

Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit is a medical device that received FDA 510(k) clearance on 2024-02-29. It is manufactured by Bd. The 510(k) number is K240257.

When was Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit approved by the FDA?

Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit received FDA 510(k) clearance on 2024-02-29, under approval number K240257.

What company makes Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit?

Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit is manufactured by Bd.

What is the FDA product code for Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit?

The FDA product code for Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit is DTK.

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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 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

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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