DTZClass II

Oxygenator, Cardiopulmonary Bypass

21 CFR 870.4350 / Cardiovascular

DTZ is the FDA product code for Oxygenator, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4350. As of 2026-09-10, FDA records hold 254 510(k) clearances under this code, the most recent dated 2026-03-16, and 107 recalls.

Classification record

Product code: DTZ
Device name: Oxygenator, Cardiopulmonary Bypass
Regulation: 21 CFR 870.4350
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k)
Implant: No
Life sustaining or supporting: Yes
GMP exempt: No
Third party review eligible: No
Ingested clearances: 255
Ingested recalls: 107

Clearances, product code DTZ

By decision year

255 clearances under product code DTZ with a decision year between 1976 and 2026, 1989 the highest year at 11.

Show the numbers

510(k) clearances under FDA product code DTZ by decision year
Year	Clearances
1976	1
1977	1
1978	4
1979	3
1980	5
1981	8
1982	7
1983	9
1984	4
1985	8
1986	8
1987	4
1988	5
1989	11
1990	9
1991	8
1992	2
1993	8
1994	5
1995	2
1996	7
1997	7
1998	3
1999	5
2000	6
2001	5
2002	6
2003	3
2004	3
2005	3
2006	3
2007	4
2008	3
2009	9
2010	2
2011	4
2012	9
2013	9
2014	5
2015	9
2016	3
2017	2
2018	3
2019	5
2020	5
2021	5
2022	2
2023	5
2024	3
2025	2
2026	3

Applicants with the most clearances

Product code DTZ

Applicants holding the most 510(k) clearances under product code DTZ
Applicant	Clearances
Medtronic, Inc.	28
Corcym Inc.	22
Dideco S.p.A.	15
American Bentley	13
MAQUET CARDIOPULMONARY GmbH	13
Terumo Cardiovascular Systems Corporation	12
Bentley Laboratories, Inc.	10
Shiley, Inc.	10
Terumo Medical Corp.	10
3M Health Care, Sarns	9

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order