LBW · Class II · 21 CFR 876.5540

FDA Product Code LBW: Set, Dialysis, Single Needle (co-axial Flow)

Leading manufacturers include Quinton, Inc., Medical Components, Inc. and Terumo Medical Corp..

5
Total
5
Cleared
31d
Avg days
1980
Since

FDA 510(k) Cleared Set, Dialysis, Single Needle (co-axial Flow) Devices (Product Code LBW)

5 devices
1–5 of 5
Cleared Nov 23, 1990
DUAL LUMEN NEEDLES
K904433
Akcess Medical Products, Inc.
Gastroenterology & Urology · 56d
Cleared Dec 16, 1986
MODIFIED DUAL LUMEN NEEDLE
K864629
Quinton, Inc.
Gastroenterology & Urology · 21d
Cleared Mar 04, 1986
DUAL LUMEN NEEDLE (PRODUCT CHANGE)
K860515
Quinton, Inc.
Gastroenterology & Urology · 21d
Cleared Apr 16, 1982
COAXIAL DUAL FLOW CATHETER
K820859
Terumo Medical Corp.
Gastroenterology & Urology · 18d
Cleared Sep 26, 1980
HEMOCATH I KIDNEY DIALYSIS CATHETER
K801968
Medical Components, Inc.
Gastroenterology & Urology · 38d

About Product Code LBW - Regulatory Context