FIE · Class II · 21 CFR 876.5540

FDA Product Code FIE: Needle, Fistula

Leading manufacturers include Jms Co., Ltd., JMS North America Corporation and Sorensen Research.

80
Total
80
Cleared
122d
Avg days
1977
Since
80 devices
49–72 of 80
Cleared Nov 20, 1990
EXEL A-V FISTULA SET
K903945
Exel Intl.
Gastroenterology & Urology · 85d
Cleared Jan 31, 1990
ARTERIOVENOUS FISTULA SETS
K900125
Baxter Healthcare Corp
Gastroenterology & Urology · 22d
Cleared Jun 22, 1989
TERUMO AV FISTULA NEEDLE SET
K891062
Terumo Medical Corp.
Gastroenterology & Urology · 113d
Cleared Mar 16, 1988
JMS APHERESIS NEEDLE
K880726
Jms Co., Ltd.
Gastroenterology & Urology · 22d
Cleared Jun 27, 1986
MEDISYSTEMS PHERESIS NEEDLE
K862002
Medisystems Corp.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1986
SUPERCATH A.V. FISTULA
K854773
Togo Medikit Co., Ltd.
Gastroenterology & Urology · 130d
Cleared Mar 18, 1986
JMD AV FISTULA NEEDLE (MODIFICATION)
K860789
Jms Co., Ltd.
Gastroenterology & Urology · 20d
Cleared Feb 26, 1986
MODIFICATION TOP ULTRA THINWALL A-V FISTULA NEEDLE
K860449
Top Corp.
Gastroenterology & Urology · 22d
Cleared Feb 05, 1986
JMS AV FISTULA NEEDLE
K860241
Jms Co., Ltd.
Gastroenterology & Urology · 12d
Cleared Jan 08, 1986
PLUME Y SET
K854951
Hospal Medical Corp.
Gastroenterology & Urology · 29d
Cleared Apr 29, 1985
HOSPAL FISTULA NEEDLE
K851453
Hospal Medical Corp.
Gastroenterology & Urology · 18d
Cleared Jan 08, 1985
TOP SINGLE USE U.T.W. A-V FISTULA NEEDLE Y TYPE
K844343
Top Surgical Manufacturers Co.
Gastroenterology & Urology · 60d
Cleared Oct 14, 1983
DUAL FLOW NEEDLE
K832136
Travenol Laboratories, S.A.
Gastroenterology & Urology · 105d
Cleared Sep 24, 1981
DELTA-A.V. FISTULA CANNULATION SET
K812621
Amisco Trading Corp.
Gastroenterology & Urology · 9d
Cleared Sep 08, 1981
MEDISYSTEMS FISTULA NEEDLE
K811838
Medisystems Corp.
Gastroenterology & Urology · 69d
Cleared Dec 22, 1980
GAMBRO A-V FISTULA NEEDLE SET
K802956
Gambro, Inc.
Gastroenterology & Urology · 32d
Cleared Sep 26, 1980
HEMO-CATH II KIDNEY DIALYSIS CATHETER
K801966
Medical Components, Inc.
Gastroenterology & Urology · 38d
Cleared Aug 13, 1980
ARGYLE A-V MEDI-WING HEMODIALYSIS SET
K801618
Sherwood Medical Co.
Gastroenterology & Urology · 29d
Cleared Aug 04, 1980
THE BELLCO FISTULA NEEDLES
K801632
Bellco Artifidial Organ Spec., Inc.
Gastroenterology & Urology · 20d
Cleared Oct 26, 1979
VITAL CATHETER
K791489
Hospal Medical Corp.
Gastroenterology & Urology · 84d
Cleared Oct 26, 1979
UNIPUNCTURE CATHETER
K791490
Hospal Medical Corp.
Gastroenterology & Urology · 84d
Cleared Mar 21, 1979
A.V. FISTULA NEEDLE SET
K782021
Cordis Corp.
Gastroenterology & Urology · 106d
Cleared Mar 17, 1978
AVF SET FOR SINGLE NEEDLE HEMODIALYSIS
K772362
Terumo America, Inc.
Gastroenterology & Urology · 80d
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (#344)
K771490
Sorensen Research
Gastroenterology & Urology · 11d