FKX · Class II · 21 CFR 876.5630

FDA Product Code FKX: System, Peritoneal, Automatic Delivery

Leading manufacturers include American Medical Products, Inc., Travenol Laboratories, S.A. and Baxter Healthcare Corp.

83
Total
83
Cleared
106d
Avg days
1977
Since
83 devices
73–83 of 83
Cleared Oct 13, 1982
SAFE LOCK TITANIUM ADAPTER SET
K822550
American Medical Products, Inc.
Gastroenterology & Urology · 50d
Cleared Sep 09, 1982
AUTOMATIC SPLICING DEVICE
K822025
E.I. Dupont DE Nemours & Co., Inc.
Gastroenterology & Urology · 59d
Cleared Sep 09, 1982
CAPD BELT
K822547
American Medical Products, Inc.
Gastroenterology & Urology · 16d
Cleared Aug 16, 1982
DIANEAL SOLUTION EXCHANGE DEVICE #5C4193
K822361
Travenol Laboratories, S.A.
Gastroenterology & Urology · 10d
Cleared Feb 19, 1982
ERIKA CAPD PREP KIT #30-9501-5
K820179
Erika, Inc.
Gastroenterology & Urology · 28d
Cleared Dec 31, 1981
CATHETER BUBBLE STAND
K813487
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 30d
Cleared Aug 31, 1981
THE AMP 80/2 PEDIATRIC CYCLER SYSTEM
K811986
American Medical Products, Inc.
Gastroenterology & Urology · 49d
Cleared May 08, 1981
CAPD CATHETER ADAPTER
K810683
American Mcgaw
Gastroenterology & Urology · 56d
Cleared Nov 16, 1979
ADR-10600(ADR 400),10601 (ADR 300)
K791342
Physio-Control Corp.
Gastroenterology & Urology · 122d
Cleared Nov 28, 1977
DIALYSIS DRAINAGE UNIT, PERITONEAL
K772150
C.R. Bard, Inc.
Gastroenterology & Urology · 14d
Cleared Oct 25, 1977
RINSE BLOCK ASSEM, D-W PERI. DIALYSIS
K771484
Quinton, Inc.
Gastroenterology & Urology · 82d