DXTClass II

Injector And Syringe, Angiographic

21 CFR 870.1650 / Cardiovascular

DXT is the FDA product code for Injector And Syringe, Angiographic, a class II device type, regulated under 21 CFR 870.1650. As of 2026-09-10, FDA records hold 210 510(k) clearances under this code, the most recent dated 2026-05-14, and 69 recalls.

Classification record

Product code: DXT
Device name: Injector And Syringe, Angiographic
Regulation: 21 CFR 870.1650
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 210
Ingested recalls: 70

Clearances, product code DXT

By decision year

210 clearances under product code DXT with a decision year between 1978 and 2026, 1988 the highest year at 13.

Show the numbers

510(k) clearances under FDA product code DXT by decision year
Year	Clearances
1978	1
1979	3
1980	2
1982	11
1983	4
1984	5
1985	3
1986	7
1987	5
1988	13
1989	4
1990	11
1991	6
1992	3
1993	3
1994	2
1995	5
1996	6
1997	6
1998	2
1999	5
2000	5
2001	5
2002	2
2003	6
2004	4
2005	4
2006	2
2007	3
2008	2
2009	6
2010	1
2011	4
2013	2
2014	6
2015	7
2016	8
2017	7
2018	9
2019	4
2020	3
2021	1
2023	1
2024	4
2025	1
2026	6

Applicants with the most clearances

Product code DXT

Applicants holding the most 510(k) clearances under product code DXT
Applicant	Clearances
Medrad, Inc.	39
Osprey Medical, Inc.	15
Acist Medical Systems, Inc.	12
Coeur, Inc.	10
Mallinckrodt Inc., Liebel-Flarsheim Business	7
Merit Medical Systems, Inc.	7
Nemoto Kyorindo Co., Ltd.	7
Vertex Medical Corp.	7
Mallinckrodt Group, Inc.	6
Coeur Laboratories, Inc.	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 99 companies shown, in name order