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FDA 510(k)

ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)

K-Number: K241507 · 2024-06-26

ApplicantAln S.A.R.L.
Decision Date2024-06-26
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) is a medical device manufactured by Aln S.A.R.L.. It received FDA 510(k) clearance on 2024-06-26 under approval number K241507. 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 ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)?

ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) is a medical device that received FDA 510(k) clearance on 2024-06-26. It is manufactured by Aln S.A.R.L.. The 510(k) number is K241507.

When was ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) approved by the FDA?

ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) received FDA 510(k) clearance on 2024-06-26, under approval number K241507.

What company makes ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)?

ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) is manufactured by Aln S.A.R.L..

What is the FDA product code for ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)?

The FDA product code for ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) is DTK.

Related Clinical Trials

NCT05785676 ALN OATF Vena Cava Filter COMPLETED

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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