FKO · Class II · 21 CFR 876.5630

FDA Product Code FKO: Catheter, Peritoneal Dialysis, Single Use

Leading manufacturers include Quinton, Inc., American Pharmaseal Div. Ahsc and Abbott Laboratories.

16
Total
16
Cleared
125d
Avg days
1976
Since

FDA 510(k) Cleared Catheter, Peritoneal Dialysis, Single Use Devices (Product Code FKO)

16 devices
1–16 of 16
Cleared Jun 26, 1998
CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS
K964514
Corpak, Inc.
Gastroenterology & Urology · 605d
Cleared Feb 27, 1998
PERITONEAL DIALYSIS CATHETER CONNECTOR
K974570
Medigroup, Inc.
Gastroenterology & Urology · 81d
Cleared Dec 09, 1987
PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM)
K874650
Quinton, Inc.
Gastroenterology & Urology · 26d
Cleared Oct 13, 1987
DIALY-NATE SET & DIALY-NATE CATHETER
K872221
Gesco Intl., Inc.
Gastroenterology & Urology · 126d
Cleared May 18, 1987
MODIFIED USE OF PULL-APART INTRODUCER SET
K871730
Quinton, Inc.
Gastroenterology & Urology · 13d
Cleared Feb 25, 1987
ACUTE PERITONEAL DIALYSIS KIT
K870472
Quinton, Inc.
Gastroenterology & Urology · 22d
Cleared Feb 14, 1986
PERITONEAL LAVAGE CATH PLC-8,SET PLS-8, KIT PLK-8
K860155
Medical Components, Inc.
Gastroenterology & Urology · 29d
Cleared Feb 21, 1985
CAPD STAGED CONNECTOR
K845041
Abbott Laboratories
Gastroenterology & Urology · 55d
Cleared Dec 18, 1981
LAZARUS-NELSON PERITONEAL LAVAGE TRAY
K813336
American Pharmaseal Div. Ahsc
Gastroenterology & Urology · 24d
Cleared Oct 19, 1981
NON-STERILE SHADOW-STRIPE CATHETER
K812717
Quinton, Inc.
Gastroenterology & Urology · 24d
Cleared Jun 18, 1981
QUINTON CATHETER FINGER GRIP
K811266
Quinton, Inc.
Gastroenterology & Urology · 37d
Cleared Dec 17, 1980
DRESSING CHANGE TRAY-MEDIUM
K802954
Associated Medical Products Co.
Gastroenterology & Urology · 27d
Cleared Oct 20, 1976
CATHETER, PERITONEAL DIALYSIS
K760544
Travenol Laboratories, S.A.
Gastroenterology & Urology · 51d

About Product Code FKO - Regulatory Context