FKX · Class II · 21 CFR 876.5630

FDA Product Code FKX: System, Peritoneal, Automatic Delivery

Leading manufacturers include Travenol Laboratories, S.A., Abbott Laboratories and Baxter Healthcare Corp.

83
Total
83
Cleared
106d
Avg days
1977
Since
83 devices
25–48 of 83
Cleared Mar 19, 1985
ABBOTT INPERSOL CYCLER 1000
K845042
Abbott Laboratories
Gastroenterology & Urology · 81d
Cleared Mar 12, 1985
ROPE SYSTEM REVERSE OSMOSIS PERITONEAL SYSTEM
K844630
Organon Teknika Corp.
Gastroenterology & Urology · 105d
Cleared Feb 21, 1985
AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM
K850406
Travenol Laboratories, S.A.
Gastroenterology & Urology · 17d
Cleared Jan 07, 1985
RENAL SYSTEMS PERITONEAL ACCESS SYSTEM
K844108
Renal Systems, Inc.
Gastroenterology & Urology · 76d
Cleared Nov 16, 1984
SCD STERILE CONNECTION DEVICE
K844144
E.I. Dupont DE Nemours & Co., Inc.
Gastroenterology & Urology · 24d
Cleared Oct 18, 1984
EXTENDED LIFE CAPD SOLUTION TRANSFER
K842885
Travenol Laboratories, S.A.
Gastroenterology & Urology · 87d
Cleared Feb 21, 1984
EXTENDED LIFE CAPD SOLUTION TRANSFER
K840224
Travenol Laboratories, S.A.
Gastroenterology & Urology · 33d
Cleared Dec 27, 1983
PERITONEAL CATHETER-CHANGES-
K833749
Quinton, Inc.
Gastroenterology & Urology · 62d
Cleared Nov 29, 1983
CAPD ULTRAVIOLET GERMICIDAL EXCHANGE
K833595
Travenol Laboratories, S.A.
Gastroenterology & Urology · 48d
Cleared Nov 28, 1983
AUTOMATIC PERITONEAL DIALYSIS CYCLER
K833065
Travenol Laboratories, S.A.
Gastroenterology & Urology · 81d
Cleared Mar 29, 1983
ABBOTT PATIENT ASSIST DEVICE
K830766
Abbott Laboratories
Gastroenterology & Urology · 19d
Cleared Mar 07, 1983
BETA-CAP D ADAPTER
K830208
Quinton, Inc.
Gastroenterology & Urology · 45d
Cleared Jan 07, 1983
STERILE, DISPOS. SPIKE PROTECTOR-5C4138
K823777
Travenol Laboratories, S.A.
Gastroenterology & Urology · 23d
Cleared Nov 30, 1982
INPERSOL PERITONEAL DIALSIS CYCLER SET
K823217
Abbott Laboratories
Gastroenterology & Urology · 33d
Cleared Oct 21, 1982
EXTENSION SET TYPE DP
K822658
Abbott Laboratories
Gastroenterology & Urology · 48d
Cleared Oct 21, 1982
INPERSOL-CAPD ADMINIS. SET TYPE DP
K822712
Abbott Laboratories
Gastroenterology & Urology · 44d
Cleared Sep 09, 1982
AUTOMATIC SPLICING DEVICE
K822025
E.I. Dupont DE Nemours & Co., Inc.
Gastroenterology & Urology · 59d
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 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