FJK · Class II · 21 CFR 876.5820

FDA Product Code FJK: Set, Tubing, Blood, With And Without Anti-regurgitation Valve

Leading manufacturers include National Medical Care, Medical Products Div., Inc., Extracorporeal Medical Specialities, Inc. and Erika, Inc..

77
Total
77
Cleared
155d
Avg days
1977
Since
77 devices
25–48 of 77
Cleared Aug 16, 2001
FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS
K012242
Fresenius Medical Care North America
Gastroenterology & Urology · 30d
Cleared Jul 28, 2000
HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0
K001873
Fresenius Medical Care North America
Gastroenterology & Urology · 38d
Cleared Jun 23, 2000
FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)
K001107
Fresenius Medical Care North America
Gastroenterology & Urology · 79d
Cleared May 09, 2000
FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290
K000451
Fresenius Medical Care North America
Gastroenterology & Urology · 88d
Cleared Feb 10, 2000
EXEL I.V. BLOOD LINE SET
K992039
Exelint Intl. Co.
Gastroenterology & Urology · 238d
Cleared Feb 09, 2000
BIOTEQUE HEMODIALYSIS BLOOD TUBING SET
K992930
Bioteque Corp.
Gastroenterology & Urology · 162d
Cleared Apr 30, 1999
EXTRACORPOREAL BLOOD CIRCUIT
K982340
Haidylena Medical Egypt
Gastroenterology & Urology · 298d
Cleared Dec 24, 1998
BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR
K983559
Icu Medical, Inc.
Gastroenterology & Urology · 72d
Cleared Oct 27, 1997
NMC HEMODIALYSIS ARTERIAL BLOOD TUBING SET
K971313
National Medical Care, Inc.
Gastroenterology & Urology · 201d
Cleared Jul 29, 1997
HEMODIALYSIS VENOUS BLOOD TUBING SET OR SIMILAR TRADE NAME
K971687
National Medical Care, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 01, 1996
COMBILINES HEMODIALYSIS BLOOD TUBING SET
K962081
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 157d
Cleared Sep 23, 1996
ARTERIAL VENOUS BLOOD TUBING SET
K953823
Medisystems Corp.
Gastroenterology & Urology · 405d
Cleared Apr 30, 1996
BRAUN HEMODIALYSIS BLOOD CIRCUITS
K952631
B.Braun Medical, Inc.
Gastroenterology & Urology · 327d
Cleared Nov 17, 1995
TS 564/PF
K950247
Bressler, Amery & Ross
Gastroenterology & Urology · 301d
Cleared Feb 24, 1995
CAVH/CVVH/CAVHD SET MODEL #HT-HF/505
K921597
Haemotronic, Inc.
Gastroenterology & Urology · 1057d
Cleared Dec 17, 1993
ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS
K934803
Baxter Healthcare Corp
Gastroenterology & Urology · 58d
Cleared Sep 21, 1992
HEMODIALYSIS BLOOD TUBING SET
K920797
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 213d
Cleared Nov 01, 1991
SERAFLO ARTERIAL AND VENOUS BLOODLINE SETS
K913526
Althin Medical AB an Affiliate of Baxter Intl
Gastroenterology & Urology · 85d
Cleared Aug 07, 1991
TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET
K910558
Terumo Medical Corp.
Gastroenterology & Urology · 180d
Cleared Nov 20, 1990
HEMODIALYSIS SYSTEM AND ACCESSORY
K902426
Gainor Medical Europe, Ltd.
Gastroenterology & Urology · 173d
Cleared Aug 14, 1990
NEGATIVE PRESSURE ARTERIAL LINE CAT. NO: 03-9630
K903021
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 34d
Cleared Aug 02, 1990
ARTERIAL/VENOUS BLOODLINES
K901688
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 112d
Cleared Apr 25, 1990
HAEMOTRONIC BLOOD LINE SET
K896407
Healthcare Suppliers, Inc.
Gastroenterology & Urology · 169d
Cleared Jun 22, 1989
BIOPRIME TM KIT
K892932
Hospal
Gastroenterology & Urology · 62d