Cleared Special

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

K241507 · Aln S.A.R.L. · Cardiovascular
Jun 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K241507 is an FDA 510(k) clearance for the ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK), a Filter, Intravascular, Cardiovascular (Class II — Special Controls, product code DTK), submitted by Aln S.A.R.L. (Bormes Les Mimosas, FR). The FDA issued a Cleared decision on June 26, 2024, 29 days after receiving the submission on May 28, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3375.

Submission Details

510(k) Number K241507 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 2024
Decision Date June 26, 2024
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTK — Filter, Intravascular, Cardiovascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.3375

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