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

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