DTKClass II

Filter, Intravascular, Cardiovascular

21 CFR 870.3375 / Cardiovascular

DTK is the FDA product code for Filter, Intravascular, Cardiovascular, a class II device type, regulated under 21 CFR 870.3375. As of 2026-09-10, FDA records hold 83 510(k) clearances under this code, the most recent dated 2024-09-10, and 22 recalls.

Classification record

Product code: DTK
Device name: Filter, Intravascular, Cardiovascular
Regulation: 21 CFR 870.3375
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 83
Ingested recalls: 22

Clearances, product code DTK

By decision year

83 clearances under product code DTK with a decision year between 1976 and 2024, 2008 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code DTK by decision year
Year	Clearances
1976	2
1977	1
1985	1
1987	1
1988	1
1989	1
1990	3
1991	2
1992	1
1993	1
1994	1
1995	3
1996	3
1997	2
2000	2
2001	3
2002	2
2003	2
2004	1
2005	3
2006	1
2007	3
2008	6
2009	3
2010	3
2011	2
2012	5
2013	3
2014	2
2015	2
2016	3
2017	5
2018	2
2021	2
2024	5

Applicants with the most clearances

Product code DTK

Applicants holding the most 510(k) clearances under product code DTK
Applicant	Clearances
C.R. Bard Inc	13
William Cook Europe ApS	12
Nitinol Medical Technologies, Inc.	7
Boston Scientific Corporation	6
Cordis US Corp.	5
Cook Inc.	4
Aln Implants Chirurgicaux	3
Edwards Laboratories	3
Medi-Tech, Inc.	3
Novate Medical, Ltd.	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order