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DTK

Filter, Intravascular, Cardiovascular

Product code
DTK
Device name
Filter, Intravascular, Cardiovascular
Device class
Class 2
21 CFR
21 CFR 870.3375
Medical specialty
Cardiovascular
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
5
Summaries archived here
4 (direct download)
510(k) clearances (all years, FDA)
83 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (5)

Last three years. Most recent: 2024-09-10.

NumberDecision dateApplicantDevice nameSummary
K2426122024-09-10Argon Medical Devices, Inc.Option ELITE Vena Cava Filter System (352506070E 352…PDF
K2405782024-07-31B.Braun Medical, Inc.VenaTech® LP Vena Cava Filter System and VenaTech® C…FDA
K2415072024-06-26Aln S.A.R.L.ALN Optional Vena Cava Filter (FB.010500, FF.010995,…PDF
K2402572024-02-29BdDenali™ Vena Cava Filter System – Femoral and Jugula…PDF
K2336802024-01-18William Cook Europe ApsCelect Platinum Vena Cava Filter Set for Femoral Vei…PDF

4 summaries are archived here for direct download.

Official FDA classification page: DTK
Classification and pathway per current FDA publications. Data from openFDA (CC0).