DTMClass II

Filter, Blood, Cardiopulmonary Bypass, Arterial Line

21 CFR 870.4260 / Cardiovascular

DTM is the FDA product code for Filter, Blood, Cardiopulmonary Bypass, Arterial Line, a class II device type, regulated under 21 CFR 870.4260. As of 2026-09-10, FDA records hold 96 510(k) clearances under this code, the most recent dated 2026-01-16, and 5 recalls.

Classification record

Product code: DTM
Device name: Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Regulation: 21 CFR 870.4260
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 96
Ingested recalls: 5

Clearances, product code DTM

By decision year

96 clearances under product code DTM with a decision year between 1978 and 2026, 1982 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code DTM by decision year
Year	Clearances
1978	1
1979	3
1980	2
1981	6
1982	7
1983	6
1984	3
1985	3
1986	4
1987	1
1988	4
1989	1
1990	3
1991	1
1993	3
1995	4
1996	1
1998	2
2000	6
2001	2
2003	6
2004	3
2005	3
2006	2
2007	3
2008	1
2009	5
2010	2
2011	1
2012	2
2013	1
2023	1
2024	2
2026	1

Applicants with the most clearances

Product code DTM

Applicants holding the most 510(k) clearances under product code DTM
Applicant	Clearances
Medtronic, Inc.	7
Bentley Laboratories, Inc.	6
Corcym Inc.	6
Terumo Cardiovascular Systems Corporation	6
American Bentley	5
Pall Biomedical Products Co.	5
Dideco S.p.A.	4
Gish Biomedical, Inc.	4
Medical, Inc.	4
Medtronic Perfusion Systems	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order