EZN · Dilator, Catheter, Ureteral
Gastroenterology, Urology · 21 CFR 876.5470 · Class 2
Overview
| Product Code | EZN |
|---|---|
| Device Name | Dilator, Catheter, Ureteral |
| Regulation | 21 CFR 876.5470 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
| 3rd-Party Reviewable | Yes |
Identification
A ureteral dilator is a device that consists of a specially shaped catheter or bougie and is used to dilate the ureter at the place where a stone has become lodged or to dilate a ureteral stricture.
Classification Rationale
Class II (performance standards).
Cleared Devices (56)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250910 | Optilume® High Pressure Urological Balloon Dilation Catheter | Urotronic, Inc. | May 22, 2025 | SESE |
| K220781 | ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter | Allwin Medical Devices, Inc. | May 5, 2023 | SESE |
| K201007 | In-Ka Ureteral Balloon Dilatation Catheter | Coloplast Corp. | Jun 11, 2020 | SESK |
| K190612 | EQUINOX Balloon Dilatation Catheter | Dornier Medtech America, Inc. | Dec 6, 2019 | SESE |
| K173654 | Ureteral Dilator Sets, Ureteral Dilators | Cook Incorporated | Jul 17, 2018 | SESE |
| K180756 | Safety Wire Guide Introducer | Cook Incorporated | May 24, 2018 | SESE |
| K180028 | Cook 810 Set, Desilets-Hoffman Introducer Set | Cook Incorporated | May 2, 2018 | SESE |
| K172588 | Balloon Catheter and Balloon Ureteral Dilator Set | Cook Incorporated | Apr 19, 2018 | SESK |
| K170531 | Ureteral Dilators and Percutaneous Nephrostomy Dilators | Coloplast Corp. | Aug 17, 2017 | SESE |
| K132181 | GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER | Olympus Surgical Technologies America | Oct 21, 2013 | SESE |
| K130804 | UROMAX ULTRA BALLOON DILATATION CATHETER | Boston Scientific Corporation | May 22, 2013 | SESE |
| K061009 | PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS | Onset Medical Corporation | May 2, 2006 | SESE |
| K050875 | U-BALLOON DILATION CATHETER | C.R. Bard, Inc. | May 26, 2005 | SESE |
| K043254 | PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH | Onset Medical Corporation | Feb 10, 2005 | SESE |
| K040127 | COOK URETERAL BALLOON DILATION CATHETER SET | Cook Urological, Inc. | Apr 6, 2004 | SESK |
| K030662 | PATHWAY ACCESS SHEATH CATHETER | Vertelink Corporation | Sep 3, 2003 | SESE |
| K993840 | BARD UROFORCE BALLOON DILATION CATHETER | C.R. Bard, Inc. | Jan 31, 2000 | SESE |
| K990072 | BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C | Cook Urological, Inc. | Mar 25, 1999 | SESE |
| K980795 | UROLOGICAL BALLOON DILATATION CATHETER | Boston Scientific Corp | Apr 22, 1998 | SESE |
| K970041 | ASCEND BALLOON DAILATION CATHETER | Cook Urological, Inc. | Mar 19, 1997 | SESE |
| K962921 | BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER | C.R. Bard, Inc. | Oct 9, 1996 | SESE |
| K953691 | MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING | Meadox Medicals, Div. Boston Scientific Corp. | Oct 16, 1995 | SESE |
| K953597 | NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER | Meadox Medicals, Div. Boston Scientific Corp. | Oct 7, 1995 | SESE |
| K953004 | DILATATION CATHETER, BALLOON | Boston Scientific Corp | Sep 13, 1995 | SESE |
| K945576 | MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R) | Meadox Medicals, Div. Boston Scientific Corp. | Jan 24, 1995 | SESE |
| K941853 | PASSPORT | Boston Scientific Corp | Sep 12, 1994 | SESE |
| K942578 | ENTRAC URETERAL BALLOON DILATATION CATHETERS | American Medical Systems, Inc. | Aug 19, 1994 | SESE |
| K940542 | NAMIC ARIA(TM) INFLATION DEVICE | American Medical Systems, Inc. | Apr 18, 1994 | SESE |
| K935379 | UROLOGICAL BALLOON DILATATION CATHETER | Boston Scientific Corp | Feb 14, 1994 | SESE |
| K933011 | MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER | Boston Scientific Corp | Feb 1, 1994 | SESE |
| K921839 | ENTRAC URETERAL BALLOON DILATION CATHETERS | American Medical Systems, Inc. | Oct 28, 1992 | SESE |
| K920946 | UROLOGICAL BALLOON DILATATION CATHETER | Boston Scientific Corp | Jul 1, 1992 | SESE |
| K915751 | URETEROMAT 4400 | F.M. Wiest USA, Inc. | Apr 24, 1992 | SESE |
| K915392 | ACCENT DG BALLOON URTERAL DILATOR SET, 10CM | Cook Urological, Inc. | Mar 18, 1992 | SESE |
| K914617 | CATHETER, URETERAL DILATOR | Boston Scientific Corp | Dec 20, 1991 | SESE |
| K912331 | URS-HYDRO-DILATOR MODEL NUMBER 2164.00 | Richard Wolf Medical Instruments Corp. | Oct 30, 1991 | SESE |
| K905375 | ACCENT DG BALLOON URETERAL DILATOR SET | Cook Urological, Inc. | Apr 12, 1991 | SESE |
| K905181 | NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY | Meadox Surgimed, Inc. | Mar 6, 1991 | SESE |
| K904983 | MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY | Meadox Surgimed, Inc. | Jan 30, 1991 | SESE |
| K903813 | URETERAL BALLOON DILATATION CATHETER | Boston Scientific Corp | Nov 7, 1990 | SESE |
| K896448 | BALLOON DILATION CATHETER | Cook Ob/Gyn | Mar 7, 1990 | SESE |
| K894925 | AMCATH URETERAL DILATORS MODELS 7100,7110,7120 | Intec Medical, Inc. | Dec 13, 1989 | SESE |
| K884711 | URETHRAL AND URETERAL BALLOON DILATATORS | Primrose Medical, Inc. | Sep 29, 1989 | SESE |
| K873178 | URETERAL BULB DILATORS | Penn Medical Devices, Inc. | Sep 30, 1987 | SESE |
| K870697 | VAN-TEC ONE STEP URETERAL DILATATION CATHETER | Van-Tec, Inc. | Mar 10, 1987 | SESE |
| K852324 | URETERAL DILATOR | American Edwards Laboratories | Aug 21, 1985 | SESE |
| K852793 | URETERAL DILATOR/SHEATH SET | American Edwards Laboratories | Aug 9, 1985 | SESE |
| K851463 | OLBERT CATHETER SYS FOR URETERAL DILATION | Meadox Surgimed, Inc. | May 23, 1985 | SESE |
| K851144 | URETERAL DILATION SET | Van-Tec, Inc. | Apr 9, 1985 | SESE |
| K850355 | MENTOR PERCUTANEOUS RENAL DILATOR SET | Mentor Corp. | Mar 12, 1985 | SESE |
| K842639 | AMER. EDWARDS LAB DIAFLEX URETERAL DILA | American Edwards Laboratories | Oct 2, 1984 | SESE |
| K842632 | DILATOR/SHEATH SET | American Edwards Laboratories | Oct 2, 1984 | SESE |
| K842206 | DIAFLEX NEPHROSTOMY BALLOON DILATOR | American Edwards Laboratories | Oct 2, 1984 | SESE |
| K841940 | VAN-TEC URETERAL DILATION BALLOON CATH | Van-Tec, Inc. | Aug 3, 1984 | SESE |
| K832808 | URETERAL DILATION SET | Van-Tec, Inc. | Oct 14, 1983 | SESE |
| K813278 | VPI URETERAL DILATATION BALLON CATHETER | Vance Products, Inc. | Dec 18, 1981 | SESE |
Top Applicants
- Boston Scientific Corp — 8 clearances
- Cook Urological, Inc. — 5 clearances
- American Edwards Laboratories — 5 clearances
- Van-Tec, Inc. — 4 clearances
- Cook Incorporated — 4 clearances
