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 Oct 14, 1983
DUAL FLOW NEEDLE
K832136
Travenol Laboratories, S.A.
Gastroenterology & Urology · 105d
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 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
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (#364)
K771491
Sorensen Research
Gastroenterology & Urology · 11d
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (#351)
K771492
Sorensen Research
Gastroenterology & Urology · 11d
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (#341)
K771493
Sorensen Research
Gastroenterology & Urology · 11d
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (354)
K771494
Sorensen Research
Gastroenterology & Urology · 11d
Cleared Aug 16, 1977
A.V. FISTULA NEEDLE SET (#361)
K771495
Sorensen Research
Gastroenterology & Urology · 11d
Cleared Jul 15, 1977
AV FISTULA NEEDLE SET
K771206
Terumo America, Inc.
Gastroenterology & Urology · 10d