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510(k) K241507

ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) by Aln S.A.R.L. — Product Code DTK

K241507 is an FDA 510(k) premarket notification submitted by Aln S.A.R.L. for the device "ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)". The FDA issued a decision of Substantially Equivalent on June 26, 2024. The device falls under product code DTK (Filter, Intravascular, Cardiovascular), a Class II device regulated under 21 CFR 870.3375.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 2024
Date Received
May 28, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filter, Intravascular, Cardiovascular
Device Class
Class II
Regulation Number
870.3375
Review Panel
CV
Submission Type

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  • K172584 — Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena (November 20, 2017)
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FDA data resources