DTK · Class II · 21 CFR 870.3375

FDA Product Code DTK: Filter, Intravascular, Cardiovascular

Leading manufacturers include William Cook Europe Aps, Bd and B.Braun Medical, Inc..

83
Total
83
Cleared
145d
Avg days
1976
Since
Growing category - 3 submissions in the last 2 years vs 2 in the prior period
Review times improving: avg 63d recently vs 148d historically

FDA 510(k) Cleared Filter, Intravascular, Cardiovascular Devices (Product Code DTK)

83 devices
1–24 of 83
Cleared Sep 10, 2024
Option ELITE Vena Cava Filter System (352506070E 352506100E)
K242612
Argon Medical Devices, Inc.
Cardiovascular · 7d
Cleared Jul 31, 2024
VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System
K240578
B.Braun Medical, Inc.
Cardiovascular · 152d
Cleared Jun 26, 2024
ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK)
K241507
Aln S.A.R.L.
Cardiovascular · 29d
Cleared Feb 29, 2024
Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit
K240257
Bd
Cardiovascular · 29d
Cleared Jan 18, 2024
Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT)
K233680
William Cook Europe Aps
Cardiovascular · 63d

About Product Code DTK - Regulatory Context

510(k) Submission Activity

83 total 510(k) submissions under product code DTK since 1976, with 83 receiving FDA clearance (average review time: 145 days).

Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under DTK have taken an average of 63 days to reach a decision - down from 148 days historically, suggesting improved FDA processing for this classification.

DTK devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →