EZN · Class II · 21 CFR 876.5470

FDA Product Code EZN: Dilator, Catheter, Ureteral

Leading manufacturers include Boston Scientific Corp, American Edwards Laboratories and Cook Urological, Inc..

56
Total
56
Cleared
106d
Avg days
1981
Since
56 devices
25–48 of 56
Cleared Jan 24, 1995
MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R)
K945576
Meadox Medicals, Div. Boston Scientific Corp.
Gastroenterology & Urology · 71d
Cleared Sep 12, 1994
PASSPORT
K941853
Boston Scientific Corp
Gastroenterology & Urology · 151d
Cleared Aug 19, 1994
ENTRAC URETERAL BALLOON DILATATION CATHETERS
K942578
American Medical Systems, Inc.
Gastroenterology & Urology · 80d
Cleared Apr 18, 1994
NAMIC ARIA(TM) INFLATION DEVICE
K940542
American Medical Systems, Inc.
Gastroenterology & Urology · 70d
Cleared Feb 14, 1994
UROLOGICAL BALLOON DILATATION CATHETER
K935379
Boston Scientific Corp
Gastroenterology & Urology · 97d
Cleared Feb 01, 1994
MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER
K933011
Boston Scientific Corp
Gastroenterology & Urology · 225d
Cleared Oct 28, 1992
ENTRAC URETERAL BALLOON DILATION CATHETERS
K921839
American Medical Systems, Inc.
Gastroenterology & Urology · 194d
Cleared Jul 01, 1992
UROLOGICAL BALLOON DILATATION CATHETER
K920946
Boston Scientific Corp
Gastroenterology & Urology · 121d
Cleared Apr 24, 1992
URETEROMAT 4400
K915751
F.M. Wiest USA, Inc.
Gastroenterology & Urology · 123d
Cleared Mar 18, 1992
ACCENT DG BALLOON URTERAL DILATOR SET, 10CM
K915392
Cook Urological, Inc.
Gastroenterology & Urology · 110d
Cleared Dec 20, 1991
CATHETER, URETERAL DILATOR
K914617
Boston Scientific Corp
Gastroenterology & Urology · 64d
Cleared Oct 30, 1991
URS-HYDRO-DILATOR MODEL NUMBER 2164.00
K912331
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 159d
Cleared Apr 12, 1991
ACCENT DG BALLOON URETERAL DILATOR SET
K905375
Cook Urological, Inc.
Gastroenterology & Urology · 133d
Cleared Mar 06, 1991
NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY
K905181
Meadox Surgimed, Inc.
Gastroenterology & Urology · 107d
Cleared Jan 30, 1991
MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY
K904983
Meadox Surgimed, Inc.
Gastroenterology & Urology · 89d
Cleared Nov 07, 1990
URETERAL BALLOON DILATATION CATHETER
K903813
Boston Scientific Corp
Gastroenterology & Urology · 79d
Cleared Mar 07, 1990
BALLOON DILATION CATHETER
K896448
Cook Ob/Gyn
Gastroenterology & Urology · 118d
Cleared Dec 13, 1989
AMCATH URETERAL DILATORS MODELS 7100,7110,7120
K894925
Intec Medical, Inc.
Gastroenterology & Urology · 133d
Cleared Sep 29, 1989
URETHRAL AND URETERAL BALLOON DILATATORS
K884711
Primrose Medical, Inc.
Gastroenterology & Urology · 325d
Cleared Sep 30, 1987
URETERAL BULB DILATORS
K873178
Penn Medical Devices, Inc.
Gastroenterology & Urology · 49d
Cleared Mar 10, 1987
VAN-TEC ONE STEP URETERAL DILATATION CATHETER
K870697
Van-Tec, Inc.
Gastroenterology & Urology · 19d
Cleared Aug 21, 1985
URETERAL DILATOR
K852324
American Edwards Laboratories
Gastroenterology & Urology · 83d
Cleared Aug 09, 1985
URETERAL DILATOR/SHEATH SET
K852793
American Edwards Laboratories
Gastroenterology & Urology · 39d
Cleared May 23, 1985
OLBERT CATHETER SYS FOR URETERAL DILATION
K851463
Meadox Surgimed, Inc.
Gastroenterology & Urology · 38d