FIE · Class II · 21 CFR 876.5540

FDA Product Code FIE: Needle, Fistula

Leading manufacturers include Jms Co., Ltd., Sorensen Research and Medisystems Corp..

80
Total
80
Cleared
122d
Avg days
1977
Since
80 devices
25–48 of 80
Cleared Jan 06, 2000
MEDISYSTEMS BUTTONHOLE NEEDLE SETS
K990803
Medisystems Corp.
Gastroenterology & Urology · 302d
Cleared Dec 17, 1999
BIOTEQUE A.V. FISTULA NEEDLE SET
K993118
Bioteque Corp.
Gastroenterology & Urology · 88d
Cleared Oct 27, 1999
SHELLY PROTECTED AV FISTULA NEEDLE
K992653
Diasol, Inc.
Gastroenterology & Urology · 82d
Cleared Aug 30, 1999
JMS A. V. FISTULA NEEDLE SET
K990470
Jms Co., Ltd.
Gastroenterology & Urology · 195d
Cleared Aug 30, 1999
JMS APHERESIS NEEDLE
K990510
Jms Co., Ltd.
Gastroenterology & Urology · 193d
Cleared Aug 09, 1999
NIPRO ARTERIAL VENOUS FISTULA NEEDLE, AGULHA PARA FISTULA ARTERIO-VENOSA, AGUJA PARA FISTULA ARTERIO VENOSA
K991623
Nipro Medical Corp.
Gastroenterology & Urology · 90d
Cleared Mar 30, 1998
JMS APHERESIS NEEDLE
K974902
Jms Co., Ltd.
Gastroenterology & Urology · 90d
Cleared Aug 07, 1997
JMS AV FISTULA NEEDLE
K970962
Jms Co., Ltd.
Gastroenterology & Urology · 143d
Cleared Jun 04, 1996
NIPRO ARTERIAL VENOUS FISTULA NEEDLE
K955182
Nissho Corp.
Gastroenterology & Urology · 204d
Cleared Oct 06, 1995
BRAUN DIACAN(R) FISTULA NEEDLES
K945850
B. Braun of America, Inc.
Gastroenterology & Urology · 310d
Cleared Feb 18, 1994
MEDISYSTEMS APHERESIS NEEDLE WITH GUARD
K932074
Medisystems Corp.
Gastroenterology & Urology · 296d
Cleared Mar 02, 1993
JMS APHERESIS NEEDLE
K915174
Jms Co., Ltd.
Gastroenterology & Urology · 473d
Cleared Aug 28, 1991
JMS AV FISTULA NEEDLES
K911199
Jms Co., Ltd.
Gastroenterology & Urology · 175d
Cleared Jun 20, 1991
MEDISYSTEMS HEMODIALYSIS FISTULA SET
K910734
Medisystems Corp.
Gastroenterology & Urology · 119d
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 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