DWFClass II

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

21 CFR 870.4210 / Cardiovascular

DWF is the FDA product code for Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4210. As of 2026-09-10, FDA records hold 401 510(k) clearances under this code, the most recent dated 2026-04-23, and 560 recalls.

Classification record

Product code: DWF
Device name: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Regulation: 21 CFR 870.4210
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: 401
Ingested recalls: 563

Clearances, product code DWF

By decision year

401 clearances under product code DWF with a decision year between 1977 and 2026, 1988 the highest year at 25.

Show the numbers

510(k) clearances under FDA product code DWF by decision year
Year	Clearances
1977	6
1978	1
1979	9
1980	10
1981	6
1982	5
1983	10
1984	16
1985	10
1986	18
1987	14
1988	25
1989	8
1990	11
1991	5
1992	4
1993	10
1994	3
1995	5
1996	9
1997	22
1998	6
1999	8
2000	13
2001	11
2002	17
2003	14
2004	8
2005	5
2006	5
2007	2
2008	6
2009	8
2010	3
2011	5
2012	10
2013	9
2014	14
2015	9
2016	3
2017	5
2018	5
2019	3
2020	3
2021	5
2022	2
2023	2
2024	3
2025	4
2026	6

Applicants with the most clearances

Product code DWF

Applicants holding the most 510(k) clearances under product code DWF
Applicant	Clearances
Medtronic, Inc.	37
Edwards Lifesciences LLC	23
3M Health Care, Sarns	21
Shiley, Inc.	21
Chase Medical, Inc.	15
Dlp, Inc.	15
Research Medical, Inc.	15
Medtronic Perfusion Systems	12
Corcym Inc.	12
Heartport, Inc.	11

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 84 companies shown, in name order