FCM · Class II · 21 CFR 876.5130

FDA Product Code FCM: Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)

Leading manufacturers include Orion Life Systems, Inc., Concord Laboratories, Inc. and Amsino International, Inc..

60
Total
60
Cleared
79d
Avg days
1976
Since
60 devices
25–48 of 60
Cleared Jul 20, 1990
CATHETER CARE TRAY
K901181
Orion Life Systems, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 20, 1990
URETHRAL CATHETER TRAY (PVC)
K901183
Orion Life Systems, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 20, 1990
URETHRAL CATHETER TRAY (LATEX)
K901184
Orion Life Systems, Inc.
Gastroenterology & Urology · 129d
Cleared Jul 20, 1990
FOLEY CATHETER INSERTION TRAY (10CC)
K901185
Orion Life Systems, Inc.
Gastroenterology & Urology · 129d
Cleared Jan 24, 1990
URETHRAL CATHETERIZATION TRAYS
K896212
Westmark, Sterile Packing Systems, Inc. (Sps)
Gastroenterology & Urology · 90d
Cleared Jul 31, 1978
URETHRO CATHETERIZATION TRAY
K780879
Abco Dealers, Inc.
Gastroenterology & Urology · 62d
Cleared Jun 24, 1977
URETHRAL TRAY W/CATHETER, 7750
K771103
Concord Laboratories, Inc.
Gastroenterology & Urology · 4d
Cleared Jun 24, 1977
URETHRAL TRAY W/OUT CAHTETER, 7650
K771104
Concord Laboratories, Inc.
Gastroenterology & Urology · 4d
Cleared Mar 21, 1977
UNIVERSAL TRAY
K770496
Concord Laboratories, Inc.
Gastroenterology & Urology · 7d
Cleared Oct 07, 1976
TRAY, CATHETERIZATION W/O CATHETER
K760127
Concord Laboratories, Inc.
Gastroenterology & Urology · 101d
Cleared Oct 07, 1976
TRAY, CATHETERIZATION W/ CATHETER
K760128
Concord Laboratories, Inc.
Gastroenterology & Urology · 101d