FDA 510(k) Applications for Medical Device Product Code "EZN"
(Dilator, Catheter, Ureteral)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K220781 | Allwin Medical Devices, Inc | 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 | 05/05/2023 |
| K980795 | BOSTON SCIENTIFIC CORP. | UROLOGICAL BALLOON DILATATION CATHETER | 04/22/1998 |
| K130804 | Boston Scientific Corporation | UROMAX ULTRA BALLOON DILATATION CATHETER | 05/22/2013 |
| K962921 | C.R. BARD, INC. | BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER | 10/09/1996 |
| K993840 | C.R. BARD, INC. | BARD UROFORCE BALLOON DILATION CATHETER | 01/31/2000 |
| K050875 | C.R. BARD, INC. | U-BALLOON DILATION CATHETER | 05/26/2005 |
| K201007 | Coloplast Corp | In-Ka Ureteral Balloon Dilatation Catheter | 06/11/2020 |
| K170531 | Coloplast Corp | Ureteral Dilators and Percutaneous Nephrostomy Dilators | 08/17/2017 |
| K172588 | Cook Incorporated | Balloon Catheter and Balloon Ureteral Dilator Set | 04/19/2018 |
| K180028 | Cook Incorporated | Cook 810 Set, Desilets-Hoffman Introducer Set | 05/02/2018 |
| K180756 | COOK Incorporated | Safety Wire Guide Introducer | 05/24/2018 |
| K173654 | Cook Incorporated | Ureteral Dilator Sets, Ureteral Dilators | 07/17/2018 |
| K970041 | COOK UROLOGICAL, INC. | ASCEND BALLOON DAILATION CATHETER | 03/19/1997 |
| K990072 | COOK UROLOGICAL, INC. | BALLOON URETERAL DILATORS, ACCENT DG BALLOON URETERAL DILATOR SET, ASCEND BALLOON DILATION CATHETERS, BALLOON DILATION C | 03/25/1999 |
| K040127 | COOK UROLOGICAL, INC. | COOK URETERAL BALLOON DILATION CATHETER SET | 04/06/2004 |
| K190612 | Dornier MedTech America Inc | EQUINOX Balloon Dilatation Catheter | 12/06/2019 |
| K132181 | OLYMPUS SURGICAL TECHNOLOGIES AMERICA | GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER | 10/21/2013 |
| K061009 | ONSET MEDICAL CORPORATION | PATHWAY BALLOON EXPANDABLE URETERAL ACCESS SHEATH, MODEL BEUS | 05/02/2006 |
| K043254 | ONSET MEDICAL CORPORATION | PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH | 02/10/2005 |
| K030662 | VERTELINK CORPORATION | PATHWAY ACCESS SHEATH CATHETER | 09/03/2003 |
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