DWSClass I

Instruments, Surgical, Cardiovascular

21 CFR 870.4500 / Cardiovascular

DWS is the FDA product code for Instruments, Surgical, Cardiovascular, a class I device type, regulated under 21 CFR 870.4500. As of 2026-09-10, FDA records hold 71 510(k) clearances under this code, the most recent dated 2002-10-09, and 20 recalls.

Classification record

Product code: DWS
Device name: Instruments, Surgical, Cardiovascular
Regulation: 21 CFR 870.4500
Device class: Class I
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: 71
Ingested recalls: 20

Clearances, product code DWS

By decision year

71 clearances under product code DWS with a decision year between 1976 and 2002, 1976 the highest year at 10.

Show the numbers

510(k) clearances under FDA product code DWS by decision year
Year	Clearances
1976	10
1977	3
1978	3
1979	5
1980	3
1981	2
1982	4
1983	3
1984	3
1985	8
1986	2
1988	9
1989	6
1990	2
1994	1
1996	5
1997	1
2002	1

Applicants with the most clearances

Product code DWS

Applicants holding the most 510(k) clearances under product code DWS
Applicant	Clearances
Edward Weck, Inc.	3
GE Healthcare	3
Manan Manufacturing Co., Inc.	3
Pilling Co.	3
Pioneering Technologies, Inc.	3
American V. Mueller	2
Cardiac Pacemakers, Inc.	2
Cerenovus, Inc.	2
Dlp, Inc.	2
Howmedica Corp.	2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 275 companies shown, in name order