DTSClass II

Sucker, Cardiotomy Return, Cardiopulmonary Bypass

21 CFR 870.4420 / Cardiovascular

DTS is the FDA product code for Sucker, Cardiotomy Return, Cardiopulmonary Bypass, a class II device type, regulated under 21 CFR 870.4420. As of 2026-09-10, FDA records hold 9 510(k) clearances under this code, the most recent dated 2006-01-26, and 11 recalls.

Classification record

Product code: DTS
Device name: Sucker, Cardiotomy Return, Cardiopulmonary Bypass
Regulation: 21 CFR 870.4420
Device class: Class II
Review panel: Cardiovascular
Submission type: 510(k) exempt
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 9
Ingested recalls: 11

Clearances, product code DTS

By decision year

9 clearances under product code DTS with a decision year between 1979 and 2006, 1980 the highest year at 2.

Show the numbers

510(k) clearances under FDA product code DTS by decision year
Year	Clearances
1979	1
1980	2
1989	1
1990	1
1991	1
1997	1
1998	1
2006	1

Applicants with the most clearances

Product code DTS

Applicants holding the most 510(k) clearances under product code DTS
Applicant	Clearances
Gish Biomedical, Inc.	2
California Medical Laboratories, Inc.	1
Dlp, Inc.	1
Estech, Inc.	1
International Biophysics Corp.	1
Ohio Medical Products	1
Shiley, Inc.	1
Texas Medical Products, Inc.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order