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 Sep 14, 1988
LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE
K870722
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 587d
Cleared Mar 14, 1986
ERIKA ARTERIAL LINE 03-9625-9
K860740
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 15d
Cleared Nov 05, 1985
ASA BLOOD TUBING LINES
K854271
Organon Teknika Corp.
Gastroenterology & Urology · 13d
Cleared Oct 18, 1985
ERIKA ARTERIAL LINE 03-9837-0
K853962
National Medical Care, Medical Products Div., Inc.
Gastroenterology & Urology · 23d
Cleared Jul 26, 1985
ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1
K852309
Erika, Inc.
Gastroenterology & Urology · 58d
Cleared Oct 14, 1983
THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101
K831424
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 164d
Cleared Apr 12, 1983
BLOOD LINE SETS FOR HEMOFILTRATION
K830677
Gambro, Inc.
Gastroenterology & Urology · 39d
Cleared May 10, 1982
TS-180 SERIES TUBING SET
K821138
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 19d
Cleared Feb 05, 1982
MALE LUER CONNECTOR & HINGED CAP
K820169
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 15d
Cleared Apr 17, 1981
ERIKA EXTENSION SETS
K810823
Erika, Inc.
Gastroenterology & Urology · 24d
Cleared Apr 17, 1981
ERIKA HEPARIN INFUSION ADAPTOR
K810824
Erika, Inc.
Gastroenterology & Urology · 24d
Cleared Nov 25, 1980
ARTERIOVENOUS BLOOD TUBING SETS
K802874
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 8d
Cleared Jul 14, 1980
COBE HEMOFLO BLOOD TUBING SETS
K801211
Cobe Laboratories, Inc.
Gastroenterology & Urology · 55d
Cleared May 30, 1980
GAMBRO G SERIES BLOOD LINE SETS FOR HEM.
K801016
Gambro, Inc.
Gastroenterology & Urology · 31d
Cleared Dec 06, 1979
ERIKA NEGATIVE PRESSURE ARTERILA BLOOD
K792053
Erika, Inc.
Gastroenterology & Urology · 52d
Cleared Dec 06, 1979
ERIKA NEGATIVE PRESSURE VENOUS BL SETS
K792054
Erika, Inc.
Gastroenterology & Urology · 52d
Cleared Jun 14, 1978
ARTERIOVENOUS BLOOD TUBING SETS
K780681
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 51d
Cleared Sep 20, 1977
CLIRANS BLOOD LINES SET
K771693
Terumo America, Inc.
Hematology · 14d
Cleared Jan 10, 1977
ARTERIOVENOUS BLOOD TUBING SETS
K761326
Extracorporeal Medical Specialities, Inc.
Gastroenterology & Urology · 14d