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
49–72 of 83
Cleared Oct 14, 1983
MICROSTAR VC1 VOLUMETRIC CYCLER
K832141
Medionics International , Ltd.
Gastroenterology & Urology · 101d
Cleared Jun 24, 1983
CAPD - CATHETER ADAPTER
K831716
American Mcgaw
Gastroenterology & Urology · 28d
Cleared Jun 02, 1983
AMPERCIDE DISINFECTANT ACCESSORY TO -
K830881
American Medical Products, Inc.
Gastroenterology & Urology · 76d
Cleared Mar 29, 1983
EMPTY DIALYSATE CONTAINER BB-69
K830689
Delmed, Inc.
Gastroenterology & Urology · 42d
Cleared Mar 29, 1983
ABBOTT PATIENT ASSIST DEVICE
K830766
Abbott Laboratories
Gastroenterology & Urology · 19d
Cleared Mar 17, 1983
AMP 80/2 OUTFLOW MONITOR MODIFICATION
K823827
American Medical Products, Inc.
Gastroenterology & Urology · 87d
Cleared Mar 07, 1983
BETA-CAP D ADAPTER
K830208
Quinton, Inc.
Gastroenterology & Urology · 45d
Cleared Feb 24, 1983
NON-STERILE PERITONEAL ACCESS CATHET-
K830257
Evermed, Inc.
Microbiology · 30d
Cleared Jan 26, 1983
PC-205 TENCKHOFF CATHETER ROD OBTURATOR
K823296
Medigroup
Gastroenterology & Urology · 82d
Cleared Jan 26, 1983
QUILL CATHETER GUIDE
K823303
Medigroup
Gastroenterology & Urology · 82d
Cleared Jan 26, 1983
DIALATORS PC-203 & 202
K823330
Medigroup
Gastroenterology & Urology · 79d
Cleared Jan 26, 1983
PC-204 TUNNELOR
K823331
Medigroup
Gastroenterology & Urology · 79d
Cleared Jan 26, 1983
PC 201A LOCKING SLEEVE
K823390
Medigroup
Gastroenterology & Urology · 82d
Cleared Jan 26, 1983
IMPRA PERITONEAL CATHETER
K823857
Impra, Inc.
Gastroenterology & Urology · 35d
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 Oct 13, 1982
CAPD SAFE LOCK TRANSFER SET
K822543
American Medical Products, Inc.
Gastroenterology & Urology · 51d
Cleared Oct 13, 1982
SAFE LOCK SEALING CAP L
K822544
American Medical Products, Inc.
Gastroenterology & Urology · 51d
Cleared Oct 13, 1982
CCPD CYCLER SET W/5 PRONGED CONNECTOR
K822545
American Medical Products, Inc.
Gastroenterology & Urology · 51d
Cleared Oct 13, 1982
SAFE LOCK SEALING CAPS
K822546
American Medical Products, Inc.
Gastroenterology & Urology · 50d
Cleared Oct 13, 1982
SAFE LOCK CATHETER S-3
K822548
American Medical Products, Inc.
Gastroenterology & Urology · 50d
Cleared Oct 13, 1982
CCPD CYCLER SET W/5 PRONGED SAFE LOCK
K822549
American Medical Products, Inc.
Gastroenterology & Urology · 50d