Dilator, Catheter, Ureteral

FDA product code EZN · 56 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5470
Review panel: GU
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1981-12-18 – 2025-05-22

EZN 2025-05-22

Optilume® High Pressure Urological Balloon Dilation Catheter

Applicant Urotronic, Inc.

K number K250910

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EZN 2023-05-05

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

Applicant Allwin Medical Devices, Inc.

K number K220781

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EZN 2020-06-11

In-Ka Ureteral Balloon Dilatation Catheter

Applicant Coloplast Corp.

K number K201007

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EZN 2019-12-06

EQUINOX Balloon Dilatation Catheter

Applicant Dornier Medtech America, Inc.

K number K190612

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EZN 2018-07-17

Ureteral Dilator Sets, Ureteral Dilators

Applicant Cook Incorporated

K number K173654

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EZN 2018-05-24

Safety Wire Guide Introducer

Applicant Cook Incorporated

K number K180756

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EZN 2018-05-02

Cook 810 Set, Desilets-Hoffman Introducer Set

Applicant Cook Incorporated

K number K180028

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EZN 2018-04-19

Balloon Catheter and Balloon Ureteral Dilator Set

Applicant Cook Incorporated

K number K172588

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EZN 2017-08-17

Ureteral Dilators and Percutaneous Nephrostomy Dilators

Applicant Coloplast Corp.

K number K170531

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EZN 2013-10-21

GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER

Applicant Olympus Surgical Technologies America

K number K132181

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EZN 2013-05-22

UROMAX ULTRA BALLOON DILATATION CATHETER

Applicant Boston Scientific Corporation

K number K130804

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EZN 2006-05-02

PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS

Applicant Onset Medical Corporation

K number K061009

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EZN 2005-05-26

U-BALLOON DILATION CATHETER

Applicant C.R. Bard, Inc.

K number K050875

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EZN 2005-02-10

PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH

Applicant Onset Medical Corporation

K number K043254

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EZN 2004-04-06

COOK URETERAL BALLOON DILATION CATHETER SET

Applicant Cook Urological, Inc.

K number K040127

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EZN 2003-09-03

PATHWAY ACCESS SHEATH CATHETER

Applicant Vertelink Corporation

K number K030662

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EZN 2000-01-31

BARD UROFORCE BALLOON DILATION CATHETER

Applicant C.R. Bard, Inc.

K number K993840

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EZN 1999-03-25

BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C

Applicant Cook Urological, Inc.

K number K990072

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EZN 1998-04-22

UROLOGICAL BALLOON DILATATION CATHETER

Applicant Boston Scientific Corp

K number K980795

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EZN 1997-03-19

ASCEND BALLOON DAILATION CATHETER

Applicant Cook Urological, Inc.

K number K970041

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EZN 1996-10-09

BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER

Applicant C.R. Bard, Inc.

K number K962921

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EZN 1995-10-16

MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K953691

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EZN 1995-10-07

NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K953597

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EZN 1995-09-13

DILATATION CATHETER, BALLOON

Applicant Boston Scientific Corp

K number K953004

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EZN 1995-01-24

MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R)

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K945576

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EZN 1994-09-12

PASSPORT

Applicant Boston Scientific Corp

K number K941853

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EZN 1994-08-19

ENTRAC URETERAL BALLOON DILATATION CATHETERS

Applicant American Medical Systems, Inc.

K number K942578

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EZN 1994-04-18

NAMIC ARIA(TM) INFLATION DEVICE

Applicant American Medical Systems, Inc.

K number K940542

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EZN 1994-02-14

UROLOGICAL BALLOON DILATATION CATHETER

Applicant Boston Scientific Corp

K number K935379

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EZN 1994-02-01

MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER

Applicant Boston Scientific Corp

K number K933011

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EZN 1992-10-28

ENTRAC URETERAL BALLOON DILATION CATHETERS

Applicant American Medical Systems, Inc.

K number K921839

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EZN 1992-07-01

UROLOGICAL BALLOON DILATATION CATHETER

Applicant Boston Scientific Corp

K number K920946

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EZN 1992-04-24

URETEROMAT 4400

Applicant F.M. Wiest USA, Inc.

K number K915751

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EZN 1992-03-18

ACCENT DG BALLOON URTERAL DILATOR SET, 10CM

Applicant Cook Urological, Inc.

K number K915392

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EZN 1991-12-20

CATHETER, URETERAL DILATOR

Applicant Boston Scientific Corp

K number K914617

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EZN 1991-10-30

URS-HYDRO-DILATOR MODEL NUMBER 2164.00

Applicant Richard Wolf Medical Instruments Corp.

K number K912331

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EZN 1991-04-12

ACCENT DG BALLOON URETERAL DILATOR SET

Applicant Cook Urological, Inc.

K number K905375

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EZN 1991-03-06

NO PROFILE OLBERT CATHETER SYSTEM FOR UROLOGY

Applicant Meadox Surgimed, Inc.

K number K905181

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EZN 1991-01-30

MEADOX(R) SURGIMED OLBERT CATH SYST FOR UROLOGY

Applicant Meadox Surgimed, Inc.

K number K904983

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EZN 1990-11-07

URETERAL BALLOON DILATATION CATHETER

Applicant Boston Scientific Corp

K number K903813

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EZN 1990-03-07

BALLOON DILATION CATHETER

Applicant Cook Ob/Gyn

K number K896448

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EZN 1989-12-13

AMCATH URETERAL DILATORS MODELS 7100,7110,7120

Applicant Intec Medical, Inc.

K number K894925

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EZN 1989-09-29

URETHRAL AND URETERAL BALLOON DILATATORS

Applicant Primrose Medical, Inc.

K number K884711

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EZN 1987-09-30

URETERAL BULB DILATORS

Applicant Penn Medical Devices, Inc.

K number K873178

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EZN 1987-03-10

VAN-TEC ONE STEP URETERAL DILATATION CATHETER

Applicant Van-Tec, Inc.

K number K870697

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EZN 1985-08-21

URETERAL DILATOR

Applicant American Edwards Laboratories

K number K852324

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EZN 1985-08-09

URETERAL DILATOR/SHEATH SET

Applicant American Edwards Laboratories

K number K852793

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EZN 1985-05-23

OLBERT CATHETER SYS FOR URETERAL DILATION

Applicant Meadox Surgimed, Inc.

K number K851463

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EZN 1985-04-09

URETERAL DILATION SET

Applicant Van-Tec, Inc.

K number K851144

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EZN 1985-03-12

MENTOR PERCUTANEOUS RENAL DILATOR SET

Applicant Mentor Corp.

K number K850355

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EZN 1984-10-02

AMER. EDWARDS LAB DIAFLEX URETERAL DILA

Applicant American Edwards Laboratories

K number K842639

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EZN 1984-10-02

DILATOR/SHEATH SET

Applicant American Edwards Laboratories

K number K842632

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EZN 1984-10-02

DIAFLEX NEPHROSTOMY BALLOON DILATOR

Applicant American Edwards Laboratories

K number K842206

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EZN 1984-08-03

VAN-TEC URETERAL DILATION BALLOON CATH

Applicant Van-Tec, Inc.

K number K841940

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EZN 1983-10-14

URETERAL DILATION SET

Applicant Van-Tec, Inc.

K number K832808

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EZN 1981-12-18

VPI URETERAL DILATATION BALLON CATHETER

Applicant Vance Products, Inc.

K number K813278

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