FDA Product Code
FDA Product Code DRE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1310
510(k) Clearances — 105 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath Set | Merit Medical Systems, Inc. | 2026-07-27 | Traditional | PDF ↗ |
| K253616 | ProtekDilate Vascular Access Kit | Sorin Group Italia S.R.L. | 2025-12-19 | Special | PDF ↗ |
| K251325 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2025-05-29 | Special | PDF ↗ |
| K242229 | Micro Ace Gold Advanced Micro Access System | Merit Medical Systems, Inc. | 2025-01-15 | Traditional | PDF ↗ |
| K241720 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2024-07-12 | Special | PDF ↗ |
| K233647 | VersaCross Connect Transseptal Dilator | Baylis Medical Company, Inc. | 2023-12-14 | Special | PDF ↗ |
| K232609 | Micro Ace Advanced Micro Access System | Merit Medical Systems, Inc. | 2023-09-27 | Special | PDF ↗ |
| K223472 | 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) | Spectranetics, Inc. | 2022-12-15 | Special | PDF ↗ |
| K212784 | TightRail Guardian Motorized Dilator Sheath | Spectranetics, Inc. | 2022-08-24 | Traditional | PDF ↗ |
| K211679 | Xtractor device | Xcardia Innovation , Ltd. | 2022-02-17 | Traditional | PDF ↗ |
| K210734 | Endovascular Dilator and Sets | Cook Incorporated | 2021-04-06 | Special | PDF ↗ |
| K201288 | ExpanSure Large Access Transseptal Dilator | Baylis Medical Company, Inc. | 2020-06-12 | Special | PDF ↗ |
| K192283 | MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator | Medron, LLC | 2020-05-06 | Traditional | PDF ↗ |
| K200379 | Super Sheath | Togo Medikit Co., Ltd. | 2020-03-19 | Special | PDF ↗ |
| K192195 | Sterile Dilator | Galt Medical Corp. | 2019-09-26 | Special | PDF ↗ |
| K190175 | S-MAK XL | Merit Medical Systems, Inc. | 2019-04-10 | Traditional | PDF ↗ |
| K182064 | ExpanSure Transseptal Dilation System | Baylis Medical Company, Inc. | 2019-03-21 | Traditional | PDF ↗ |
| K183036 | Dilator Sets | Cook Incorporated | 2018-12-20 | Traditional | PDF ↗ |
| K182914 | MC3 Vascular Access Kit 21030 | Mc3 Incorporated | 2018-10-29 | Traditional | PDF ↗ |
| K172487 | Coaxial Dilator Set (Micro-Introducer) | Galt Medical Corp. | 2017-10-16 | Traditional | PDF ↗ |
| K162389 | Medcomp Vessel Dilator | Medcomp ( Medical Components) | 2017-06-01 | Traditional | PDF ↗ |
| K170616 | van Andel Dilatation Catheter | Cook Incorporated | 2017-04-28 | Traditional | PDF ↗ |
| K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set | Cardiacassist, Inc. | 2017-01-06 | Traditional | PDF ↗ |
| K161336 | VSI StraitSet micro-introducer kit | Vascular Solutions, Inc. | 2016-08-11 | Traditional | PDF ↗ |
| K150932 | Sheath Introducer | Bioteque Corp. | 2016-07-22 | Traditional | PDF ↗ |
| K161333 | TightRail Sub-C Rotating Dilator Sheath | Spectranetics, Inc. | 2016-07-08 | Traditional | PDF ↗ |
| K151877 | MicroTract Access System | Arstasis, Inc. | 2015-08-07 | Special | PDF ↗ |
| K151076 | MicroTaper Needle Introducer Set | Summit Access, LLC | 2015-05-22 | Traditional | PDF ↗ |
| K150360 | TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath | Spectranetics, Inc. | 2015-03-04 | Special | PDF ↗ |
| K141070 | SUPER SHEATH | Togo Medikit Co., Ltd. | 2015-01-15 | Traditional | PDF ↗ |
| K142301 | Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath | Cook Vascular, Inc. | 2014-11-12 | Traditional | PDF ↗ |
| K142546 | TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath | Spectranetics, Inc. | 2014-09-25 | Traditional | PDF ↗ |
| K141148 | EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET | Cook Vascular, Inc. | 2014-07-01 | Traditional | PDF ↗ |
| K141131 | TIGHTRAIL MINI | Spectranetics, Inc. | 2014-05-23 | Special | PDF ↗ |
| K140047 | LEXICONTURE MECHANICAL DILATOR SHEATH SET | Spectranetics Corp. | 2014-04-09 | Traditional | PDF ↗ |
| K133631 | LEXIPLIANT DILATOR SHEATH SET | Spectranetics Corporation | 2014-03-27 | Traditional | PDF ↗ |
| K132713 | NMI COAXIAL MICROINTRODUCER SET | Navilyst Medical, Inc. | 2013-09-27 | Special | PDF ↗ |
| K123842 | LAWMAX DILATOR | Lifetech Scientific (Shenzhen) Co., Ltd. | 2013-06-24 | Traditional | PDF ↗ |
| K130791 | PRELUDE SHEATH INTRODUCER | Merit Medical Systems, Inc. | 2013-06-07 | Special | PDF ↗ |
| K123445 | NMI COAXIAL MICROINTRODUCER SET | Navilyst Medical, Inc. | 2013-04-01 | Traditional | PDF ↗ |
| K120349 | SONIXGPS VASCULAR ACCESS NEEDLE KIT | Ultrasonix Medical Corpation | 2012-04-09 | Traditional | PDF ↗ |
| K103421 | ARSTASIS DILATOR ADAPTER | Arstasis, Inc. | 2011-05-24 | Traditional | PDF ↗ |
| K093554 | RETROFLEX DILATOR KIT | Edwards Lifesciences, LLC | 2010-04-13 | Traditional | PDF ↗ |
| K092378 | SPECTRANETICS VISISHEATH DILATOR SHEATH | Spectranetics Corp. | 2009-11-02 | Traditional | PDF ↗ |
| K091584 | MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE | Merit Medical Systems, Inc. | 2009-10-09 | Traditional | PDF ↗ |
| K081940 | AVALON ELITE VASCULAR ACCESS KIT | Avalon Laboratories, LLC | 2008-11-18 | Traditional | PDF ↗ |
| K082075 | HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER | Hansen Medical, Inc. | 2008-08-15 | Special | PDF ↗ |
| K073035 | PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS | Merit Medical Systems, Inc. | 2007-11-20 | Special | PDF ↗ |
| K071330 | GALTSTICK INTRODUCER SYSTEM | Galt Medical Corp. | 2007-10-31 | Special | PDF ↗ |
| K070749 | ESTECH PERCUTANEOUS INSERTION DILATOR KIT | Coombs Medical Device Consulting | 2007-10-24 | Traditional | PDF ↗ |
| K070159 | PRELUDE SHEATH INTRODUCER | Merit Medical Systems, Inc. | 2007-06-21 | Special | PDF ↗ |
| K062554 | STARCLOSE HEX-HUB DILATOR | Abbott Vascular, Inc. | 2007-02-06 | Traditional | PDF ↗ |
| K061000 | EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 | Cook Vascular, Inc. | 2006-05-10 | Special | PDF ↗ |
| K052557 | SUPER SHEATH INTRODUCER SHEATH | Togo Medikit Co., Ltd. | 2006-01-17 | Traditional | PDF ↗ |
| K050962 | MERIT PRELUDE SHEATH INTRODUCER | Merit Medical Systems, Inc. | 2005-05-06 | Traditional | PDF ↗ |
| K031691 | MERIT MAK (MINI ACCESS KIT) | Merit Medical Systems, Inc. | 2003-09-03 | Abbreviated | PDF ↗ |
| K030260 | GELBFISH FLEX VASCULAR DILATOR | Vascumetrix, LLC | 2003-02-20 | Special | PDF ↗ |
| K023507 | MODIFICATION TO GELBFISH VASCULAR DILATORS | Vascumetrix, LLC | 2002-11-08 | Special | PDF ↗ |
| K012256 | GELBISH VASCULAR DILATOR | Vascumetrix, LLC | 2001-12-20 | Traditional | PDF ↗ |
| K010055 | COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH | Cook Vascular, Inc. | 2001-06-14 | Traditional | PDF ↗ |
| K000737 | COAXIAL DILATOR SET | Xentek Medical, Inc. | 2000-08-01 | Traditional | PDF ↗ |
| K974617 | PERIPHERAL VASCULAR DILATOR | Endovascular Instruments, Inc. | 1998-12-01 | Traditional | PDF ↗ |
| K980282 | URESIL DILATOR WITH RADIOPAQUE MARKER | Uresil Corp. | 1998-04-24 | Traditional | PDF ↗ |
| K974640 | COAXIAL DILATOR SET | Boston Scientific Corp | 1998-03-13 | Traditional | PDF ↗ |
| K970470 | EVT EXPANDABLE SHEATH | Guidant Cardiac and Vascular Surgery | 1997-07-31 | Traditional | PDF ↗ |
| K970392 | CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM | Cordis Corp. | 1997-04-24 | Traditional | PDF ↗ |
| K945586 | FLEXIBLE DILATING SHEATH | Med Institute, Inc. | 1997-04-04 | Traditional | PDF ↗ |
| K963388 | VESSEL DILATOR | Maxxim Medical | 1997-03-11 | Traditional | PDF ↗ |
| K960917 | PERCUGLIDE | Scientific Device Manufacturer, LLC | 1996-07-02 | Traditional | PDF ↗ |
| K914555 | WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI) | Med Institute, Inc. | 1992-01-03 | Traditional | PDF ↗ |
| K913027 | VESSEL DILATOR | Deseret Medical, Inc. | 1991-11-27 | Traditional | PDF ↗ |
| K912050 | NOVOSTE VESSEL DILATER | Novaste Corp. | 1991-10-09 | Traditional | PDF ↗ |
| K905416 | VESSEL DILATOR | The R Group | 1991-03-25 | Traditional | PDF ↗ |
| K904476 | VESSEL DILATOR | Datascope Corp. | 1990-12-10 | Traditional | PDF ↗ |
| K902469 | BYRD DILATOR SHEATH SET - TEFLON | Medical Engineering and Development Institute | 1990-08-23 | Traditional | PDF ↗ |
| K901815 | MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY | Pioneering Technologies, Inc. | 1990-07-03 | Traditional | PDF ↗ |
| K896096 | SOLOSTICK (AMPLATZ DILATOR NEEDLE) | Microvena Corp. | 1990-04-10 | Traditional | PDF ↗ |
| K894330 | DAIG VESSEL DILATOR | Daig Corp. | 1989-09-12 | Traditional | PDF ↗ |
| K882238 | VESSEL DILATOR AND INTRODUCER SHEATH | Ideal Medical, Inc. | 1988-08-25 | Traditional | PDF ↗ |
| K881073 | SHILEY FEMORAL CANNULAE INTRODUCER KIT | Shiley, Inc. | 1988-06-09 | Traditional | PDF ↗ |
| K874738 | 10 AND 12 FRENCH VESSEL DILATORS | Impra, Inc. | 1988-05-02 | Traditional | PDF ↗ |
| K875327 | MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT | Schneider-Shilley (Usa) | 1988-03-25 | Traditional | PDF ↗ |
| K872724 | SHEATH/DILATORS | Med-West, Inc. | 1987-09-15 | Traditional | PDF ↗ |
| K870413 | PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR) | Medical Surgical Concepts, Inc. | 1987-06-01 | Traditional | PDF ↗ |
| K871148 | URESIL CAROTID ARTERY SIZERS | Uresil Corp. | 1987-04-22 | Traditional | PDF ↗ |
| K862288 | MODIFICATION OF TISSUE DILATOR | Quinton, Inc. | 1986-08-19 | Traditional | PDF ↗ |
| K860161 | HEART CATHETERIZATION TRAY | Medical Design Concepts, Inc. | 1986-05-02 | Traditional | PDF ↗ |
| K850337 | CARDIAC CATHETERIZATION PACK | Marwood Medical, Inc. | 1985-02-25 | Traditional | PDF ↗ |
| K843261 | ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD | Angiosystems, Inc. | 1984-09-11 | Traditional | PDF ↗ |
| K842113 | AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT | Mallinckrodt Critical Care | 1984-07-13 | Traditional | PDF ↗ |
| K841995 | 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK | Quinton, Inc. | 1984-07-02 | Traditional | PDF ↗ |
| K840671 | CARDIAC CATHETERIZATION PACK | Professional Medical Services | 1984-03-12 | Traditional | PDF ↗ |
| K840017 | VERTEX PERCUTANEOUS CATHETER INTRODUC | Professional Medical Services | 1984-02-04 | Traditional | PDF ↗ |
| K840022 | HEART CATHETERIZATION TRAY SET | Medi-Plast Intl., Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K833965 | 8 FRENCH DILATOR 15CM, W/LUER LOCK | Quinton, Inc. | 1983-12-16 | Traditional | PDF ↗ |
| K831190 | VESSEL DILATOR | Medrad, Inc. | 1983-05-09 | Traditional | PDF ↗ |
| K822595 | VESSEL DILATOR | Vertex Medical Corp. | 1982-09-28 | Traditional | PDF ↗ |
| K813461 | PERCUTANEOUS ENTRY NEEDLE, SELDINGER | Ocean Medical Products, Ltd. | 1981-12-29 | Traditional | PDF ↗ |
| K813125 | MICRO TRANSDUCER CATHETERS | Honeywell, Inc. | 1981-12-14 | Traditional | PDF ↗ |
| K810859 | SINGLE USE SELDINGER/COURNAND PERC. NDL | Procedure Products, Inc. | 1981-04-11 | Traditional | PDF ↗ |
Product code DRE · Class II · Cardiovascular. Data: openFDA.