KDJ · Class II · 21 CFR 876.5630

FDA Product Code KDJ: Set, Administration, For Peritoneal Dialysis, Disposable

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

113
Total
113
Cleared
107d
Avg days
1977
Since
113 devices
73–96 of 113
Cleared Jul 16, 1987
DELFLEX RIGID DRAIN CONTAINER
K871155
Delmed, Inc.
Gastroenterology & Urology · 114d
Cleared Jul 09, 1987
MODIFIED LABELING FOR AMUKIN-50%
K871583
Amuchina Intl., Inc.
Gastroenterology & Urology · 77d
Cleared Jun 03, 1987
FREEDOM SET II WITH TRIFLEX VALVE
K870626
Delmed, Inc.
Gastroenterology & Urology · 110d
Cleared Apr 30, 1987
DELFLEX SAFE LOCK CAPD PATIENT ASSIST DEVICE
K871154
Delmed, Inc.
Gastroenterology & Urology · 37d
Cleared Apr 10, 1987
CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN.
K871049
Abbott Laboratories
Gastroenterology & Urology · 24d
Cleared Apr 10, 1987
CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM.
K871050
Abbott Laboratories
Gastroenterology & Urology · 24d
Cleared Mar 10, 1987
EXTERNAL Y VALVE 5C4198
K870145
Travenol Laboratories, S.A.
Gastroenterology & Urology · 56d
Cleared Apr 07, 1986
CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186
K860700
Travenol Laboratories, S.A.
Gastroenterology & Urology · 41d
Cleared Feb 05, 1986
CAPD TRANSFER SET SPIKE 5C4363
K860230
Travenol Laboratories, S.A.
Gastroenterology & Urology · 14d
Cleared Oct 04, 1985
TRAVENOL CAPD Y SET 5C4354
K853550
Travenol Laboratories, S.A.
Gastroenterology & Urology · 39d
Cleared Jul 29, 1985
CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353
K852678
Travenol Laboratories, S.A.
Gastroenterology & Urology · 34d
Cleared Apr 08, 1985
EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153
K851207
Travenol Laboratories, S.A.
Gastroenterology & Urology · 13d
Cleared Apr 08, 1985
COMPACT EXCHANGE DEVICE 5C4197
K851208
Travenol Laboratories, S.A.
Gastroenterology & Urology · 13d
Cleared Jun 30, 1982
CARD U.V. GERMICIDAL CHAMBER II
K820546
Travenol Laboratories, S.A.
Gastroenterology & Urology · 120d
Cleared Mar 02, 1982
CAPD U.V. GERMICIDAL CONNECTION SYSTEM
K812802
Travenol Laboratories, S.A.
Gastroenterology & Urology · 147d
Cleared Nov 16, 1981
PERITONEAL DIALYSIS CYCLER SET
K813069
American Medical Products, Inc.
Gastroenterology & Urology · 17d
Cleared Oct 19, 1981
PERITONEAL DIALYSIS DRAINAGE
K812771
Dravon Medical, Inc.
Gastroenterology & Urology · 14d
Cleared Oct 19, 1981
PERITONEAL DIALYSIS CYCLER SET (8UNIT)
K812772
Dravon Medical, Inc.
Gastroenterology & Urology · 14d
Cleared Sep 21, 1981
STERI-TRACT
K811863
Rogo Ent.
Gastroenterology & Urology · 82d
Cleared Sep 09, 1981
SPIKE GUARD
K812130
Clinipad Corp.
Gastroenterology & Urology · 44d
Cleared Jun 12, 1981
GAMBRO PERITONEAL DIALYSIS FLUID LINES
K811294
Gambro, Inc.
Gastroenterology & Urology · 32d
Cleared Apr 29, 1981
AMP PERITONEAL DIALYSIS PREP KIT
K810840
American Medical Products, Inc.
Gastroenterology & Urology · 33d
Cleared Mar 24, 1981
CAPD EXCHANGE SET
K810600
American Mcgaw
Gastroenterology & Urology · 18d
Cleared Mar 24, 1981
CCPD CYCLER SET
K810670
American Medical Products, Inc.
Gastroenterology & Urology · 12d