FDA 510(k) Applications for Medical Device Product Code "EZL"
(Catheter, Retention Type, Balloon)

FDA 510(k) Number Applicant Device Name Decision Date
K022287 3T MEDICAL SYSTEMS, LLC. 3T/SEWOON TEMPERATURE SENSING FOLEY CATHETERS 09/23/2002
K051059 AMSINO INTERNATIONAL, INC. AMSURE 100% SILICONE FOLEY CATHETER 06/28/2005
K101824 AMSINO INTERNATIONAL, INC. AMSURE 3-WAY HYDROPHILIC LATEX FOLEY CATHETER 09/13/2010
K030120 AMSINO INTERNATIONAL, INC. AMSURE FOLEY CATHETER 10/29/2003
K091699 AMSINO INTERNATIONAL, INC. AMSURE HYDROPHILIC LATEX FOLEY CATHETER 08/10/2009
K010006 APPLIED MEDICAL RESOURCES CORP. DRAINAGE CATHETER OR FOLEY CATHETER 07/25/2001
K934895 AXIOM MEDICAL, INC. GLASSMAN SILICONE CATHETER 10/13/1994
K984084 BARD MEDICAL DIV. BARDEX LUBRI-SIL FOLEY CATHETER 02/01/1999
K944007 BAXTER HEALTHCARE CORP. EUROPHILIC SLIPPERY COATED FOLEY CATHETER 06/29/1995
K042110 BEAMPOINT AB BEAMCATH 02/25/2005
K935630 BEIERSDORF, INC. NORTA 10/07/1994
K002868 C.R. BARD, INC. BARD ALL-SILICONE 3-WAY FOLEY CATHETER; BARD LUBRI-SIL 3-WAY FOLEY CATHETER; BARD LUBRI-SIL I.C. 3-WAY FOLEY CATHETER 12/08/2000
K150699 C.R. Bard, Inc. Bard LubriGuard Foley Catheter 07/28/2015
K070582 C.R. BARD, INC. BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS 12/07/2007
K002612 C.R. BARD, INC. BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON 09/03/2002
K003289 C.R. BARD, INC. BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU 01/05/2001
K070508 C.R. BARD, INC. BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR 03/09/2007
K070558 C.R. BARD, INC. BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS 12/07/2007
K040504 C.R. BARD, INC. BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS 05/14/2004
K951103 C.R. BARD, INC. SILASTIC BRAND FOLEY CATHETER 04/28/1995
K172807 Changzhou Rongxin Medicine Minimal Invasion Technology Silicone Foley Catheter for single use 06/04/2018
K772218 CONCORD LABORATORIES, INC. CATHETER, SILICONE COATED 12/13/1977
K964757 CONTIMED, INC. CONTIDRAIN CATHETER 06/25/1997
K173657 Cook Incorporated Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter 08/23/2018
K091767 COOK UROLOGICAL, INC. 3 WAY SILICONE FOLEY BALLOON CATHETER 10/09/2009
K951106 COOK UROLOGICAL, INC. SILICONE FOLEY CATHETER 05/25/1995
K930344 COOK UROLOGICAL, INC. SILICONE FOLEY CATHETER 04/15/1994
K150550 COVALON TECHNOLOGIES, INC. SilverCoat Silicone Foley Catheter 11/24/2015
K063442 DEGANIA SILICONE, LTD. ALL SILICONE FOLEY CATHETER, 2-WAY, 3-WAY, WITH TEMPERATURE SENSOR 03/26/2007
K103371 DEGANIA SILICONE, LTD. COUDE/ OR TIEMANN 03/11/2011
K131020 DEGANIA SILICONE, LTD. TEMPERATURE SENSOR CATHETER 05/09/2013
K181346 Emmy Medical, LLC. CystoSure Plus Catheter 08/06/2018
K053429 ENTRACARE, LLC ADVANCED UROLOGICAL CATHETER 02/08/2006
K932809 EXCALIBUR ENGINEERING CARE OF RMS, INC. FRANGI-CATH SAFE-RELEASE(TM) CONNECTOR 03/17/1994
K980919 FORTUNE MEDICAL INSTRUMENT CORP. ALL SILICONE 2-WAY & 3-WAY FOLY BALLOON CATHETER AND NELATON CATHETER 03/31/1998
K021142 FORTUNE MEDICAL INSTRUMENT CORP. ALL SILICONE HEMATURIA CATHETER, MODELS 4861, 4862, 4863, 4864, 4865 10/01/2002
K130908 GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD DISPOSABLE SILICONE FOLEY CATHETER 10/03/2013
K990509 IMPLEMED, INC. OLIGON FOLEY CATHETER (16 FR) #33816/OLIGON FOLEY CATHETER (18 FR) #33818 05/18/1999
K173340 Jiangxi Yikang Medical Instrument Group Co., LTD. Yikang Latex Foley Catheter 07/13/2018
K780062 KENDALL RESEARCH CENTER CATHETER/HEMOSTATIC/GERIATRIC 02/14/1978
K971801 LOUISVILLE LABORATORIES, INC. LAPAROTOMY BLADDER NECK SUSPENSION KIT 07/22/1997
K971796 LOUISVILLE LABORATORIES, INC. LAPAROTOMY BLADDER NECK SUSPENSION KIT WITH BONE ANCHORS 08/12/1997
K961697 MEDICAL DEVICE INTL., INC. OPTICON FEMALE URINARY INCONTINENCE CATHETER FOR CONTINUOUS DRAINAGE 08/30/1996
K941488 MEDICAL TECHNOLOGY DEVELOPMENT CORP. DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER 11/30/1994
K071423 MEDLINE INDUSTRIES, INC. MEDLINE LATEX FOLEY CATHETER 07/18/2007
K142635 MEDLINE INDUSTRIES, INC. Medline Silicone Foley Catheter 01/09/2015
K052168 MEDLINE INDUSTRIES, INC. MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC. 02/16/2006
K982626 MEDWORKS CORP. URETHROPEXY SUTURE PLACEMENT KIT MODEL NUMBERS UM-300, MW-100, MINI-LAPAROTOMY MMK KIT MODEL UM-250, LAPAROSCOPIC BURCH0 08/20/1998
K003784 MENTOR CORP. MENTOR SELF-CATH PLUS 03/05/2001
K944676 MRI MANUFACTURING AND RESEARCH, INC. MRI'S ALL SILICONE FOLEY CATHETER 04/05/1996
K982970 MRI MANUFACTURING AND RESEARCH, INC. MRI'S ALL SILICONE IRRIGATION 3-WAY FOLEY CATHETER 10/28/1998
K172422 Nellie Medical, LLC Kohli Urinary Drainage Catheter 02/09/2018
K041983 OPTICON MEDICAL OPTION-VM URINARY CATHETER/ADPATER, MODELS MV39016, MVA39016 11/17/2004
K970716 OPTICON MEDICAL, INC. OPTICON DIRECT MALE URINARY CATHETER FOR CONTINUOUS DRAINAGE 05/16/1997
K033830 OPTICON MEDICAL, INC. OPTION-VF URINARY CATHETER WITH ADAPTOR, MODEL FVA14218; OPTION-V CONTINUOUS DRAINAGE ADAPTOR, MODEL CDA1000 01/09/2004
K023090 OPTICON MEDICAL, INC. OPTION-VF URINARY CATHETER, FV14218 03/19/2003
K110214 PERCUVISION DIRECTVISION CATHETER, UNCOATED 05/27/2011
K090262 PERCUVISION LLC PERCUCATH URINARY CATHETER 05/28/2009
K173533 Poiesis Medical, LLC Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter 03/29/2018
K771860 POLYSIL, INC. FOLHY CATHETER 10/18/1977
K013172 PORGES S.A. PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL 12/20/2001
K013174 PORGES S.A. PROGES FOLYSIL SILICONE FOLEY CATHETER, STRAIGHT CYLINDRICAL TIP, SILICONE FEMALE FOLEY CATHETER, STRAIGHT CYLINDRICAL, 01/04/2002
K153655 POTRERO MEDICAL, INC. Accuryn Monitoring System 04/15/2016
K030813 PRIMARY CARE SOLUTIONS, INC. PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INFLATION SYRINGES WITH STERILE WATER CATALOG NUMBERS 1010 AND 05/30/2003
K944673 REGULATORY & MARKETING SERVICES, INC. MRI'S ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE 04/10/1996
K944376 REGULATORY & MARKETING SERVICES, INC. ORION ALL SILICONE ELASTOMER COATED CATHETER 11/30/1994
K944382 REGULATORY & MARKETING SERVICES, INC. ORION ALL SILICONE FOLEY CATHETER 12/06/1994
K944381 REGULATORY & MARKETING SERVICES, INC. ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE 11/30/1994
K944380 REGULATORY & MARKETING SERVICES, INC. ORION FOLEY CATHETER 11/30/1994
K954752 REGULATORY & MARKETING SERVICES, INC. PEDIATRIC EUROPHYLIC FOLEY CATHETER 10/30/1995
K981612 ROCHESTER MEDICAL CORP. ALL SILICONE FOLEY CATHETER, TWO-WAY FOLEY CATHETER, THREE-WAY FOLEY CATHETER, TWO-WAY RADIOPAQUE FOLEY CATHETER 07/08/1998
K905042 ROCHESTER MEDICAL CORP. COMFORT SLEEVED ALL SILICONE FOLEY CATHETER 01/18/1991
K941692 ROCHESTER MEDICAL CORP. FEMALE LENGTH ALL SILICONE UROLOGICAL CATHETER 03/06/1995
K971643 RUSCH INTL. RUSCH BRILLANT BALLOON CATHETER 10/07/1997
K993063 RUSCH INTL. RUSCH BRILLANT SILICONE FOLEY 12/09/1999
K972184 RUSCH INTL. RUSCH BRILLANT SILICONE FOLEY CATHETER 01/08/1998
K964575 RUSCH INTL. SYMPACATH HYDROGEL COATED FOLEY 02/04/1997
K980870 RUSCH, INC. RUSCH SILICONE FOLEY CATHETER 06/09/1998
K974419 RUSCH, INC. RUSCH SIMPLASTIC COUNCILL TIP CATHETER 01/27/1998
K140099 SEEDINGS LIFE SCIENCE VENTURES, LLC LIGHTHOUSE URINARY CATHETER 03/04/2014
K131655 SEEDINGS LIFE SCIENCE VENTURES, LLC LIGHTHOUSE(TM) URINARY CATHETER 11/04/2013
K013276 SEWOON MEDICAL CO., LTD. ALL-SILICONE FOLEY BALLOON CATHETER (TWO WAY; THREE WAY, RADIOPAQUE) 02/15/2002
K902710 SOCIETA GRUPPI ELASTOMERI S.A. FOLEY CATHETER 11/21/1990
K062112 SUNMED, INC. SUNMED FOLEY CATHETERS 06/04/2007
K161770 Teleflex Medical, Inc. Rusch Silicone Foley Catheter 05/05/2017
K162989 TELEFLEX MEDICAL, INC. Rusch Simplastic Foley Catheters 02/24/2017
K990500 THE KENDAL CO. KENDALL ULTRAMER COUDE FOLEY CATHETER, MODEL 1416C, KENDALL CURITY COUDE FOLEY CATHETER TRAY, MODEL 6946C 09/28/1999
K024010 THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER 06/11/2003
K071049 TYCO HEALTHCARE DOVER 100% SILICONE FOLEY CATHETER WITH TEMPERATURE SENSOR 10/16/2007
K042709 TYCO HEALTHCARE DOVER SILVER TEMPERATURE SENSING FOLEY CATHETER 01/18/2005
K082919 UC-CARE MEDICAL SYSTEMS LTD UC-CARE POSITIONING SYSTEM 10/27/2008
K973076 UNOMEDICAL SDN BHD EUROMEDICAL HAEMATURIA FOLEY CATHETER 09/16/1998
K945806 UNOMEDICAL SDN BHD SILICATH ALL SILICONE FOLEY CATHETER 03/21/1995
K911617 UROTECH U.S.A., INC. UROTECH CATHETER 02/25/1993
K894883 VITAID, LTD. PHYCON ALL SILICONE BALLOON CATHETER 04/25/1990
K031748 VITALCARE GROUP, INC. VITALCARE STERILEWATER AND 0.9% SODIUM CHLORIDE PRE-FILLED 10CC/30CC SYRINGES 08/27/2003
K021939 VITALCARE, INC. VITALCARE FOLEY CATHETER 04/22/2003
K140667 WELL LEAD MEDICAL CO. LTD WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER 12/15/2014
K091516 WELL LEAD MEDICAL CO. LTD WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR 10/16/2009
K082815 WELL LEAD MEDICAL INSTRUMENTS WELL LEAD SILICONE AND LATEX FOLEY CATHETERS 10/08/2008
K903777 WEMBLEY RUBBER PRODUCTS (M) SDN BHD WRP FOLEYCATH 12/13/1990
K922821 YELLOW SPRINGS INSTRUMENT CO., INC. YSI MODELS 4700 FOLEY CATHETER TEMPERATURE PROBES 11/23/1992
K921561 YSIS, INC YSI MODELS 4400 FOLEY CATHETER TEMPERATURE PROBES 11/23/1992


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