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 07, 2002
SHARGHP A.V. FISTULA NEEDLE SET
K013384
Shargh Pharmaceutical Co., Inc.
Gastroenterology & Urology · 87d
Cleared Dec 07, 2001
EXCEL A.V FISUTAL NEEDLE SET
K013037
Exelint Intl. Co.
Gastroenterology & Urology · 88d
Cleared Sep 06, 2001
JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE
K002352
Jms Co., Ltd.
Gastroenterology & Urology · 400d
Cleared May 04, 2001
RENAX A.V. FISTULA NEEDLE SETS
K003123
Sunder Biomedical Tech. Co., Ltd.
Gastroenterology & Urology · 211d
Cleared Nov 21, 2000
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
K002813
Nipro Medical Corp.
Gastroenterology & Urology · 74d
Cleared Aug 01, 2000
A.V. FISTULA NEEDLE
K001496
Exelint International, Co.
Gastroenterology & Urology · 78d
Cleared Apr 10, 2000
MODIFICATION TO JMS APHERESIS NEEDLE
K000843
Jms Co., Ltd.
Gastroenterology & Urology · 26d
Cleared Apr 10, 2000
MODIFICATION TO JMS A.V. FISTULA NEEDLE SET
K000845
Jms Co., Ltd.
Gastroenterology & Urology · 26d
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 Apr 20, 1992
VIVAMED FISTULA NEEDLE
K903440
S.S. Ent.
Gastroenterology & Urology · 629d
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 Mar 01, 1991
NEEDLE, DIALYSIS
K902564
Gainor Medical Europe, Ltd.
Gastroenterology & Urology · 263d