DQXClass II

Wire, Guide, Catheter

21 CFR 870.1330 / Cardiovascular

DQX is the FDA product code for Wire, Guide, Catheter, a class II device type, regulated under 21 CFR 870.1330. As of 2026-09-10, FDA records hold 766 510(k) clearances under this code, the most recent dated 2026-07-14, and 258 recalls.

Classification record

Product code: DQX
Device name: Wire, Guide, Catheter
Regulation: 21 CFR 870.1330
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: 768
Ingested recalls: 258

Clearances, product code DQX

By decision year

768 clearances under product code DQX with a decision year between 1976 and 2026, 1995 the highest year at 34.

Show the numbers

510(k) clearances under FDA product code DQX by decision year
Year	Clearances
1976	1
1977	4
1978	4
1979	3
1980	2
1981	1
1982	4
1983	2
1984	6
1985	9
1986	22
1987	12
1988	23
1989	15
1990	15
1991	22
1992	27
1993	32
1994	22
1995	34
1996	26
1997	26
1998	20
1999	16
2000	16
2001	12
2002	20
2003	22
2004	21
2005	14
2006	12
2007	14
2008	19
2009	18
2010	21
2011	18
2012	20
2013	18
2014	18
2015	15
2016	14
2017	19
2018	19
2019	13
2020	14
2021	6
2022	15
2023	10
2024	11
2025	10
2026	11

Applicants with the most clearances

Product code DQX

Applicants holding the most 510(k) clearances under product code DQX
Applicant	Clearances
Boston Scientific Corporation	69
Asahi Intecc Co., Ltd.	47
Advanced Cardiovascular Systems, Inc.	45
Lake Region Mfg., Inc.	31
Scimed Life Systems, Inc.	30
Cordis US Corp.	25
Medtronic, Inc.	23
Merit Medical Systems, Inc.	22
Target Therapeutics	22
Abbott Vascular	19

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 190 companies shown, in name order