DREClass II

Dilator, Vessel, For Percutaneous Catheterization

21 CFR 870.1310 / Cardiovascular

DRE is the FDA product code for Dilator, Vessel, For Percutaneous Catheterization, a class II device type, regulated under 21 CFR 870.1310. As of 2026-09-10, FDA records hold 105 510(k) clearances under this code, the most recent dated 2026-07-27, and 40 recalls.

Classification record

Product code: DRE
Device name: Dilator, Vessel, For Percutaneous Catheterization
Regulation: 21 CFR 870.1310
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: 105
Ingested recalls: 40

Clearances, product code DRE

By decision year

105 clearances under product code DRE with a decision year between 1976 and 2026, 1984 the highest year at 6.

Show the numbers

510(k) clearances under FDA product code DRE by decision year
Year	Clearances
1976	1
1978	1
1980	3
1981	3
1982	1
1983	2
1984	6
1985	1
1986	2
1987	3
1988	4
1989	1
1990	4
1991	3
1992	1
1996	1
1997	4
1998	3
2000	1
2001	2
2002	1
2003	2
2005	1
2006	2
2007	5
2008	2
2009	2
2010	1
2011	1
2012	1
2013	4
2014	6
2015	4
2016	3
2017	4
2018	2
2019	3
2020	3
2021	1
2022	3
2023	2
2024	1
2025	3
2026	1

Applicants with the most clearances

Product code DRE

Applicants holding the most 510(k) clearances under product code DRE
Applicant	Clearances
Merit Medical Systems, Inc.	10
Spectranetics Corp.	9
Baylis Medical Co., Inc.	5
Cook Vandergrift, Inc.	4
Cook Incorporated	3
Galt Medical Corp	3
Boston Scientific Corporation	3
Quinton, Inc.	3
Togo Medikit Co., Ltd.	3
Vascumetrix, LLC	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 75 companies shown, in name order