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FDA 510(k)

ALN Filtro de Vena Cava Opcional (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)

Número K: K241507 · 2024-06-26

RequerenteAln S.A.R.L.
Data da decisão2024-06-26
Código do produtoDTK
Comité consultivoCV
DecisãoSubstantially Equivalent

Resumo do dispositivo

ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) is the device name listed in this FDA 510(k) record. The listed applicant is Aln S.A.R.L.. It received FDA 510(k) clearance on 2024-06-26 under 510(k) number K241507. The device is classified under product code DTK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Aln S.A.R.L.. The 510(k) number is K241507.

When did ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) receive FDA 510(k) clearance?

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 510(k) number K241507.

Who is the listed applicant for ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)?

The FDA 510(k) record lists Aln S.A.R.L. as the applicant. This does not by itself establish the device manufacturer.

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.

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Dispositivos Relacionados (Código: DTK)

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Fonte oficial

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