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 |
| 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 |
| K201288 | Baylis Medical Company Inc. | ExpanSure Large Access Transseptal Dilator | 06/12/2020 |
| K182064 | Baylis Medical Company Inc. | ExpanSure Transseptal Dilation System | 03/21/2019 |
| 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 |
| K183036 | Cook Incorporated | Dilator Sets | 12/20/2018 |
| K210734 | Cook Incorporated | Endovascular Dilator and Sets | 04/06/2021 |
| 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 |
| 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 |
| K192195 | Galt Medical Corp. | Sterile Dilator | 09/26/2019 |
| 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 |
| K123842 | LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. | LAWMAX DILATOR | 06/24/2013 |
| K963388 | MAXXIM MEDICAL | VESSEL DILATOR | 03/11/1997 |
| K182914 | MC3 Incorporated | MC3 Vascular Access Kit 21030 | 10/29/2018 |
| K945586 | MED INSTITUTE, INC. | FLEXIBLE DILATING SHEATH | 04/04/1997 |
| K162389 | MEDCOMP ( MEDICAL COMPONENTS) | Medcomp Vessel Dilator | 06/01/2017 |
| K192283 | Medron, LLC | MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator | 05/06/2020 |
| K190175 | Merit Medical Systems Inc. | S-MAK XL | 04/10/2019 |
| 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 |
| K232609 | Merit Medical Systems, Inc. | Micro AceÖ Advanced Micro Access System | 09/27/2023 |
| K073035 | MERIT MEDICAL SYSTEMS, INC. | PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS | 11/20/2007 |
| K070159 | MERIT MEDICAL SYSTEMS, INC. | PRELUDE SHEATH INTRODUCER | 06/21/2007 |
| K130791 | MERIT MEDICAL SYSTEMS, INC. | PRELUDE SHEATH INTRODUCER | 06/07/2013 |
| K123445 | NAVILYST MEDICAL, INC. | NMI COAXIAL MICROINTRODUCER SET | 04/01/2013 |
| K132713 | NAVILYST MEDICAL, INC. | NMI COAXIAL MICROINTRODUCER SET | 09/27/2013 |
| K960917 | SCIENTIFIC DEVICE MANUFACTURER LLC. | PERCUGLIDE | 07/02/1996 |
| 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 |
| K223472 | Spectranetics Inc. | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) | 12/15/2022 |
| K212784 | Spectranetics, Inc. | TightRail Guardian Motorized Dilator Sheath | 08/24/2022 |
| 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 |
| K151076 | Summit Access, LLC | MicroTaper Needle Introducer Set | 05/22/2015 |
| K200379 | TOGO MEDIKIT CO., LTD. | Super Sheath | 03/19/2020 |
| 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 |
| K980282 | URESIL CORP. | URESIL DILATOR WITH RADIOPAQUE MARKER | 04/24/1998 |
| 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 |
| K211679 | Xcardia Innovation Ltd. | Xtractor device | 02/17/2022 |
| K000737 | XENTEK MEDICAL, INC. | COAXIAL DILATOR SET | 08/01/2000 |
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