| FlexTract Deflectable-Rotational Dilator Sheath Set (K261310) | Merit Medical Systems, Inc. | 2026-07-27 |
| ProtekDilate Vascular Access Kit (K253616) | Sorin Group Italia S.R.L. | 2025-12-19 |
| VersaCross Connect™ Transseptal Dilator (K251325) | Baylis Medical Company, Inc. | 2025-05-29 |
| Micro Ace Gold Advanced Micro Access System (K242229) | Merit Medical Systems, Inc. | 2025-01-15 |
| VersaCross Connect™ Transseptal Dilator (K241720) | Baylis Medical Company, Inc. | 2024-07-12 |
| VersaCross Connect™ Transseptal Dilator (K233647) | Baylis Medical Company, Inc. | 2023-12-14 |
| Micro Ace™ Advanced Micro Access System (K232609) | Merit Medical Systems, Inc. | 2023-09-27 |
| 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) (K223472) | Spectranetics, Inc. | 2022-12-15 |
| TightRail Guardian Motorized Dilator Sheath (K212784) | Spectranetics, Inc. | 2022-08-24 |
| Xtractor device (K211679) | Xcardia Innovation , Ltd. | 2022-02-17 |
| Endovascular Dilator and Sets (K210734) | Cook Incorporated | 2021-04-06 |
| ExpanSure Large Access Transseptal Dilator (K201288) | Baylis Medical Company, Inc. | 2020-06-12 |
| MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator (K192283) | Medron, LLC | 2020-05-06 |
| Super Sheath (K200379) | Togo Medikit Co., Ltd. | 2020-03-19 |
| Sterile Dilator (K192195) | Galt Medical Corp. | 2019-09-26 |
| S-MAK XL (K190175) | Merit Medical Systems, Inc. | 2019-04-10 |
| ExpanSure Transseptal Dilation System (K182064) | Baylis Medical Company, Inc. | 2019-03-21 |
| Dilator Sets (K183036) | Cook Incorporated | 2018-12-20 |
| MC3 Vascular Access Kit 21030 (K182914) | Mc3 Incorporated | 2018-10-29 |
| Coaxial Dilator Set (Micro-Introducer) (K172487) | Galt Medical Corp. | 2017-10-16 |
| Medcomp Vessel Dilator (K162389) | Medcomp ( Medical Components) | 2017-06-01 |
| van Andel Dilatation Catheter (K170616) | Cook Incorporated | 2017-04-28 |
| Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set (K162181) | Cardiacassist, Inc. | 2017-01-06 |
| VSI StraitSet micro-introducer kit (K161336) | Vascular Solutions, Inc. | 2016-08-11 |
| Sheath Introducer (K150932) | Bioteque Corp. | 2016-07-22 |
| TightRail Sub-C Rotating Dilator Sheath (K161333) | Spectranetics, Inc. | 2016-07-08 |
| MicroTract Access System (K151877) | Arstasis, Inc. | 2015-08-07 |
| MicroTaper Needle Introducer Set (K151076) | Summit Access, LLC | 2015-05-22 |
| TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath (K150360) | Spectranetics, Inc. | 2015-03-04 |
| SUPER SHEATH (K141070) | Togo Medikit Co., Ltd. | 2015-01-15 |
| Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath (K142301) | Cook Vascular, Inc. | 2014-11-12 |
| TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath (K142546) | Spectranetics, Inc. | 2014-09-25 |
| EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET (K141148) | Cook Vascular, Inc. | 2014-07-01 |
| TIGHTRAIL MINI (K141131) | Spectranetics, Inc. | 2014-05-23 |
| LEXICONTURE MECHANICAL DILATOR SHEATH SET (K140047) | Spectranetics Corp. | 2014-04-09 |
| LEXIPLIANT DILATOR SHEATH SET (K133631) | Spectranetics Corporation | 2014-03-27 |
| NMI COAXIAL MICROINTRODUCER SET (K132713) | Navilyst Medical, Inc. | 2013-09-27 |
| LAWMAX DILATOR (K123842) | Lifetech Scientific (Shenzhen) Co., Ltd. | 2013-06-24 |
| PRELUDE SHEATH INTRODUCER (K130791) | Merit Medical Systems, Inc. | 2013-06-07 |
| NMI COAXIAL MICROINTRODUCER SET (K123445) | Navilyst Medical, Inc. | 2013-04-01 |
| SONIXGPS VASCULAR ACCESS NEEDLE KIT (K120349) | Ultrasonix Medical Corpation | 2012-04-09 |
| ARSTASIS DILATOR ADAPTER (K103421) | Arstasis, Inc. | 2011-05-24 |
| RETROFLEX DILATOR KIT (K093554) | Edwards Lifesciences, LLC | 2010-04-13 |
| SPECTRANETICS VISISHEATH DILATOR SHEATH (K092378) | Spectranetics Corp. | 2009-11-02 |
| MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE (K091584) | Merit Medical Systems, Inc. | 2009-10-09 |
| AVALON ELITE VASCULAR ACCESS KIT (K081940) | Avalon Laboratories, LLC | 2008-11-18 |
| HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER (K082075) | Hansen Medical, Inc. | 2008-08-15 |
| PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS (K073035) | Merit Medical Systems, Inc. | 2007-11-20 |
| GALTSTICK INTRODUCER SYSTEM (K071330) | Galt Medical Corp. | 2007-10-31 |
| ESTECH PERCUTANEOUS INSERTION DILATOR KIT (K070749) | Coombs Medical Device Consulting | 2007-10-24 |
| PRELUDE SHEATH INTRODUCER (K070159) | Merit Medical Systems, Inc. | 2007-06-21 |
| STARCLOSE HEX-HUB DILATOR (K062554) | Abbott Vascular, Inc. | 2007-02-06 |
| EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 (K061000) | Cook Vascular, Inc. | 2006-05-10 |
| SUPER SHEATH INTRODUCER SHEATH (K052557) | Togo Medikit Co., Ltd. | 2006-01-17 |
| MERIT PRELUDE SHEATH INTRODUCER (K050962) | Merit Medical Systems, Inc. | 2005-05-06 |
| MERIT MAK (MINI ACCESS KIT) (K031691) | Merit Medical Systems, Inc. | 2003-09-03 |
| GELBFISH FLEX VASCULAR DILATOR (K030260) | Vascumetrix, LLC | 2003-02-20 |
| MODIFICATION TO GELBFISH VASCULAR DILATORS (K023507) | Vascumetrix, LLC | 2002-11-08 |
| GELBISH VASCULAR DILATOR (K012256) | Vascumetrix, LLC | 2001-12-20 |
| COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH (K010055) | Cook Vascular, Inc. | 2001-06-14 |
| COAXIAL DILATOR SET (K000737) | Xentek Medical, Inc. | 2000-08-01 |
| PERIPHERAL VASCULAR DILATOR (K974617) | Endovascular Instruments, Inc. | 1998-12-01 |
| URESIL DILATOR WITH RADIOPAQUE MARKER (K980282) | Uresil Corp. | 1998-04-24 |
| COAXIAL DILATOR SET (K974640) | Boston Scientific Corp | 1998-03-13 |
| EVT EXPANDABLE SHEATH (K970470) | Guidant Cardiac and Vascular Surgery | 1997-07-31 |
| CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM (K970392) | Cordis Corp. | 1997-04-24 |
| FLEXIBLE DILATING SHEATH (K945586) | Med Institute, Inc. | 1997-04-04 |
| VESSEL DILATOR (K963388) | Maxxim Medical | 1997-03-11 |
| PERCUGLIDE (K960917) | Scientific Device Manufacturer, LLC | 1996-07-02 |
| WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI) (K914555) | Med Institute, Inc. | 1992-01-03 |
| VESSEL DILATOR (K913027) | Deseret Medical, Inc. | 1991-11-27 |
| NOVOSTE VESSEL DILATER (K912050) | Novaste Corp. | 1991-10-09 |
| VESSEL DILATOR (K905416) | The R Group | 1991-03-25 |
| VESSEL DILATOR (K904476) | Datascope Corp. | 1990-12-10 |
| BYRD DILATOR SHEATH SET - TEFLON (K902469) | Medical Engineering and Development Institute | 1990-08-23 |
| MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY (K901815) | Pioneering Technologies, Inc. | 1990-07-03 |
| SOLOSTICK (AMPLATZ DILATOR NEEDLE) (K896096) | Microvena Corp. | 1990-04-10 |
| DAIG VESSEL DILATOR (K894330) | Daig Corp. | 1989-09-12 |
| VESSEL DILATOR AND INTRODUCER SHEATH (K882238) | Ideal Medical, Inc. | 1988-08-25 |
| SHILEY FEMORAL CANNULAE INTRODUCER KIT (K881073) | Shiley, Inc. | 1988-06-09 |
| 10 AND 12 FRENCH VESSEL DILATORS (K874738) | Impra, Inc. | 1988-05-02 |
| MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT (K875327) | Schneider-Shilley (Usa) | 1988-03-25 |
| SHEATH/DILATORS (K872724) | Med-West, Inc. | 1987-09-15 |
| PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR) (K870413) | Medical Surgical Concepts, Inc. | 1987-06-01 |
| URESIL CAROTID ARTERY SIZERS (K871148) | Uresil Corp. | 1987-04-22 |
| MODIFICATION OF TISSUE DILATOR (K862288) | Quinton, Inc. | 1986-08-19 |
| HEART CATHETERIZATION TRAY (K860161) | Medical Design Concepts, Inc. | 1986-05-02 |
| CARDIAC CATHETERIZATION PACK (K850337) | Marwood Medical, Inc. | 1985-02-25 |
| ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD (K843261) | Angiosystems, Inc. | 1984-09-11 |
| AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT (K842113) | Mallinckrodt Critical Care | 1984-07-13 |
| 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK (K841995) | Quinton, Inc. | 1984-07-02 |
| CARDIAC CATHETERIZATION PACK (K840671) | Professional Medical Services | 1984-03-12 |
| HEART CATHETERIZATION TRAY SET (K840022) | Medi-Plast Intl., Inc. | 1984-02-04 |
| VERTEX PERCUTANEOUS CATHETER INTRODUC (K840017) | Professional Medical Services | 1984-02-04 |
| 8 FRENCH DILATOR 15CM, W/LUER LOCK (K833965) | Quinton, Inc. | 1983-12-16 |
| VESSEL DILATOR (K831190) | Medrad, Inc. | 1983-05-09 |
| VESSEL DILATOR (K822595) | Vertex Medical Corp. | 1982-09-28 |
| PERCUTANEOUS ENTRY NEEDLE, SELDINGER (K813461) | Ocean Medical Products, Ltd. | 1981-12-29 |
| MICRO TRANSDUCER CATHETERS (K813125) | Honeywell, Inc. | 1981-12-14 |
| SINGLE USE SELDINGER/COURNAND PERC. NDL (K810859) | Procedure Products, Inc. | 1981-04-11 |