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
73–80 of 80
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
Cleared Jun 24, 1977
HEMODIALYSIS FISTULA SET
K770864
Venospital, Inc.
Gastroenterology & Urology · 44d
Cleared Jun 14, 1977
NEEDLE SET, A-V FISTULA
K770699
Medical Disposables Intl., Inc.
Gastroenterology & Urology · 57d