FDA 510(k) Applications for Medical Device Product Code "DRE"
(Dilator, Vessel, For Percutaneous Catheterization)

FDA 510(k) Number Applicant Device Name Decision Date
K062554 ABBOTT VASCULAR INC. STARCLOSE HEX-HUB DILATOR 02/06/2007
K801113 ALVA MEDICAL, INC. DILATOR, VESSEL, FOR PERC. CATHETER. 07/28/1980
K843261 ANGIOSYSTEMS, INC. ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD 09/11/1984
K780126 ARGON MEDICAL CORP. DILATOR, VESSEL & INTRODUCER, SHEATH 03/02/1978
K103421 ARSTASIS, INC. ARSTASIS DILATOR ADAPTER 05/24/2011
K151877 ARSTASIS, INC. MicroTract Access System 08/07/2015
K081940 AVALON LABORATORIES, LLC AVALON ELITE VASCULAR ACCESS KIT 11/18/2008
K150932 BIOTEQUE CORP. Sheath Introducer 07/22/2016
K974640 BOSTON SCIENTIFIC CORP. COAXIAL DILATOR SET 03/13/1998
K162181 CARDIACASSIST INC. Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set 01/06/2017
K170616 Cook Incorporated van Andel Dilatation Catheter 04/28/2017
K010055 COOK VASCULAR, INC. COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH 06/14/2001
K061000 COOK VASCULAR, INC. EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 05/10/2006
K142301 COOK VASCULAR, INC. Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath 11/12/2014
K141148 COOK VASCULAR, INC. EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET 07/01/2014
K070749 COOMBS MEDICAL DEVICE CONSULTING ESTECH PERCUTANEOUS INSERTION DILATOR KIT 10/24/2007
K970392 CORDIS CORP. CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM 04/24/1997
K894330 DAIG CORP. DAIG VESSEL DILATOR 09/12/1989
K904476 DATASCOPE CORP. VESSEL DILATOR 12/10/1990
K913027 DESERET MEDICAL, INC. VESSEL DILATOR 11/27/1991
K093554 EDWARDS LIFESCIENCES, LLC. RETROFLEX DILATOR KIT 04/13/2010
K974617 ENDOVASCULAR INSTRUMENTS, INC. PERIPHERAL VASCULAR DILATOR 12/01/1998
K172487 Galt Medical Corp. Coaxial Dilator Set (Micro-Introducer) 10/16/2017
K071330 GALT MEDICAL CORP. GALTSTICK INTRODUCER SYSTEM 10/31/2007
K970470 GUIDANT CARDIAC AND VASCULAR SURGERY EVT EXPANDABLE SHEATH 07/31/1997
K082075 HANSEN MEDICAL, INC. HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER 08/15/2008
K813125 HONEYWELL, INC. MICRO TRANSDUCER CATHETERS 12/14/1981
K882238 IDEAL MEDICAL, INC. VESSEL DILATOR AND INTRODUCER SHEATH 08/25/1988
K874738 IMPRA, INC. 10 AND 12 FRENCH VESSEL DILATORS 05/02/1988
K123842 LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. LAWMAX DILATOR 06/24/2013
K842113 MALLINCKRODT CRITICAL CARE AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT 07/13/1984
K850337 MARWOOD MEDICAL, INC. CARDIAC CATHETERIZATION PACK 02/25/1985
K963388 MAXXIM MEDICAL VESSEL DILATOR 03/11/1997
K945586 MED INSTITUTE, INC. FLEXIBLE DILATING SHEATH 04/04/1997
K914555 MED INSTITUTE, INC. WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI) 01/03/1992
K872724 MED-WEST, INC. SHEATH/DILATORS 09/15/1987
K162389 MEDCOMP ( MEDICAL COMPONENTS) Medcomp Vessel Dilator 06/01/2017
K840022 MEDI-PLAST INTL., INC. HEART CATHETERIZATION TRAY SET 02/04/1984
K800462 MEDICAL COMPONENTS, INC. PERCUTANEOUS INTRODUCER SET 03/19/1980
K860161 MEDICAL DESIGN CONCEPTS, INC. HEART CATHETERIZATION TRAY 05/02/1986
K902469 MEDICAL ENGINEERING AND DEVELOPMENT INSTITUTE BYRD DILATOR SHEATH SET - TEFLON 08/23/1990
K870413 MEDICAL SURGICAL CONCEPTS, INC. PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR) 06/01/1987
K831190 MEDRAD, INC. VESSEL DILATOR 05/09/1983
K031691 MERIT MEDICAL SYSTEMS, INC. MERIT MAK (MINI ACCESS KIT) 09/03/2003
K091584 MERIT MEDICAL SYSTEMS, INC. MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE 10/09/2009
K050962 MERIT MEDICAL SYSTEMS, INC. MERIT PRELUDE SHEATH INTRODUCER 05/06/2005
K073035 MERIT MEDICAL SYSTEMS, INC. PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS 11/20/2007
K130791 MERIT MEDICAL SYSTEMS, INC. PRELUDE SHEATH INTRODUCER 06/07/2013
K070159 MERIT MEDICAL SYSTEMS, INC. PRELUDE SHEATH INTRODUCER 06/21/2007
K896096 MICROVENA CORP. SOLOSTICK (AMPLATZ DILATOR NEEDLE) 04/10/1990
K123445 NAVILYST MEDICAL, INC. NMI COAXIAL MICROINTRODUCER SET 04/01/2013
K132713 NAVILYST MEDICAL, INC. NMI COAXIAL MICROINTRODUCER SET 09/27/2013
K912050 NOVASTE CORP. NOVOSTE VESSEL DILATER 10/09/1991
K813461 OCEAN MEDICAL PRODUCTS, LTD. PERCUTANEOUS ENTRY NEEDLE, SELDINGER 12/29/1981
K901815 PIONEERING TECHNOLOGIES, INC. MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY 07/03/1990
K810859 PROCEDURE PRODUCTS, INC. SINGLE USE SELDINGER/COURNAND PERC. NDL 04/11/1981
K840671 PROFESSIONAL MEDICAL SERVICES CARDIAC CATHETERIZATION PACK 03/12/1984
K840017 PROFESSIONAL MEDICAL SERVICES VERTEX PERCUTANEOUS CATHETER INTRODUC 02/04/1984
K841995 QUINTON, INC. 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK 07/02/1984
K833965 QUINTON, INC. 8 FRENCH DILATOR 15CM, W/LUER LOCK 12/16/1983
K862288 QUINTON, INC. MODIFICATION OF TISSUE DILATOR 08/19/1986
K875327 SCHNEIDER-SHILLEY (USA) MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT 03/25/1988
K960917 SCIENTIFIC DEVICE MANUFACTURER LLC. PERCUGLIDE 07/02/1996
K881073 SHILEY, INC. SHILEY FEMORAL CANNULAE INTRODUCER KIT 06/09/1988
K140047 SPECTRANETICS CORP. LEXICONTURE MECHANICAL DILATOR SHEATH SET 04/09/2014
K092378 SPECTRANETICS CORP. SPECTRANETICS VISISHEATH DILATOR SHEATH 11/02/2009
K133631 SPECTRANETICS CORPORATION LEXIPLIANT DILATOR SHEATH SET 03/27/2014
K141131 SPECTRANETICS, INC. TIGHTRAIL MINI 05/23/2014
K150360 SPECTRANETICS, INC. TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath 03/04/2015
K142546 SPECTRANETICS, INC. TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath 09/25/2014
K161333 Spectranetics, Inc. TightRail Sub-C Rotating Dilator Sheath 07/08/2016
K802327 STANCO MEDICAL, INC. SHEATH DILATOR SET 10/10/1980
K151076 Summit Access, LLC MicroTaper Needle Introducer Set 05/22/2015
K905416 THE R GROUP VESSEL DILATOR 03/25/1991
K141070 TOGO MEDIKIT CO., LTD. SUPER SHEATH 01/15/2015
K052557 TOGO MEDIKIT CO., LTD. SUPER SHEATH INTRODUCER SHEATH 01/17/2006
K120349 ULTRASONIX MEDICAL CORPATION SONIXGPS VASCULAR ACCESS NEEDLE KIT 04/09/2012
K871148 URESIL CORP. URESIL CAROTID ARTERY SIZERS 04/22/1987
K980282 URESIL CORP. URESIL DILATOR WITH RADIOPAQUE MARKER 04/24/1998
K760403 USCI, DIV. C.R. BARD, INC. TEMPORARY ATRIAL ELECTRODE KIT 08/23/1976
K161336 VASCULAR SOLUTIONS, INC. VSI StraitSet micro-introducer kit 08/11/2016
K030260 VASCUMETRIX, LLC GELBFISH FLEX VASCULAR DILATOR 02/20/2003
K012256 VASCUMETRIX, LLC GELBISH VASCULAR DILATOR 12/20/2001
K023507 VASCUMETRIX, LLC MODIFICATION TO GELBFISH VASCULAR DILATORS 11/08/2002
K822595 VERTEX MEDICAL CORP. VESSEL DILATOR 09/28/1982
K000737 XENTEK MEDICAL, INC. COAXIAL DILATOR SET 08/01/2000


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