DTLClass II

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

21 CFR 870.4290 / Cardiovascular

DTL is the FDA product code for Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4290. As of 2026-09-10, FDA records hold 137 510(k) clearances under this code, the most recent dated 2015-12-02, and 59 recalls.

Classification record

Product code: DTL
Device name: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Regulation: 21 CFR 870.4290
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 137
Ingested recalls: 59

Clearances, product code DTL

By decision year

137 clearances under product code DTL with a decision year between 1976 and 2015, 1979 the highest year at 9.

Show the numbers

510(k) clearances under FDA product code DTL by decision year
Year	Clearances
1976	1
1977	1
1978	3
1979	9
1980	7
1981	4
1982	2
1983	4
1984	4
1985	7
1986	9
1987	4
1988	5
1989	7
1990	7
1991	5
1992	2
1993	3
1994	2
1995	5
1996	5
1997	1
1999	3
2001	1
2002	2
2003	3
2004	4
2005	1
2006	2
2007	1
2008	5
2009	2
2010	4
2012	8
2013	1
2014	2
2015	1

Applicants with the most clearances

Product code DTL

Applicants holding the most 510(k) clearances under product code DTL
Applicant	Clearances
Merit Medical Systems, Inc.	10
Boston Scientific Corporation	5
North American Instrument Corp.	5
Texas Medical Products, Inc.	5
Advance Medical Designs Inc	4
C.R. Bard Inc	4
Gish Biomedical, Inc.	4
L.O.N. Research, Inc.	4
Medtronic, Inc.	4
Terumo Cardiovascular Systems Corporation	4

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 119 companies shown, in name order