ClearanceBrief
Panels › Cardiovascular › Product code DRE · Class 2

Dilator, Vessel, For Percutaneous Catheterization

Regulation 870.1310

2510(k)s in 12 months (105 all time)
1recalls in 12 months (40 all time)
36recalls that name a 510(k)
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Top companies in DRE

Company510(k)sRecalls
Merit Medical Systems, Inc.106
Angiodynamics, Inc.015
Spectranetics Corp.90
Boston Scientific Corp16
Galt Medical Corp.33
Argon Medical Devices, Inc05
Baylis Medical Company, Inc.50
Cook Vascular, Inc.40
Cook Incorporated30
Cordis Corp.12
Decided510(k)Device and applicantCode
Jul 27, 2026K261310FlexTract Deflectable-Rotational Dilator Sheath Set
Merit Medical Systems, Inc.
DRE
Dec 19, 2025K253616ProtekDilate Vascular Access Kit
Sorin Group Italia S.R.L., IT
DRE
May 29, 2025K251325VersaCross Connect™ Transseptal Dilator
Baylis Medical Company, Inc., CA
DRE
Jan 15, 2025K242229Micro Ace Gold Advanced Micro Access System
Merit Medical Systems, Inc.
DRE
Jul 12, 2024K241720VersaCross Connect™ Transseptal Dilator
Baylis Medical Company, Inc., CA
DRE
Dec 14, 2023K233647VersaCross Connect™ Transseptal Dilator
Baylis Medical Company, Inc., CA
DRE
Sep 27, 2023K232609Micro Ace™ Advanced Micro Access System
Merit Medical Systems, Inc.
DRE
Dec 15, 2022K223472TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French
Spectranetics, Inc.
DRE
Aug 24, 2022K212784TightRail Guardian Motorized Dilator Sheath
Spectranetics, Inc.
DRE
Feb 17, 2022K211679Xtractor device
Xcardia Innovation , Ltd., IL
DRE
Apr 6, 2021K210734Endovascular Dilator and Sets
Cook Incorporated
DRE
Jun 12, 2020K201288ExpanSure Large Access Transseptal Dilator
Baylis Medical Company, Inc., CA
DRE
May 6, 2020K192283MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator
Medron, LLC
DRE
Mar 19, 2020K200379Super Sheath
Togo Medikit Co., Ltd., JP
DRE
Sep 26, 2019K192195Sterile Dilator
Galt Medical Corp.
DRE
Apr 10, 2019K190175S-MAK XL
Merit Medical Systems, Inc.
DRE
Mar 21, 2019K182064ExpanSure Transseptal Dilation System
Baylis Medical Company, Inc., CA
DRE
Dec 20, 2018K183036Dilator Sets
Cook Incorporated
DRE
Oct 29, 2018K182914MC3 Vascular Access Kit 21030
Mc3 Incorporated
DRE
Oct 16, 2017K172487Coaxial Dilator Set (Micro-Introducer)
Galt Medical Corp.
DRE
Jun 1, 2017K162389Medcomp Vessel Dilator
Medcomp ( Medical Components)
DRE
Apr 28, 2017K170616van Andel Dilatation Catheter
Cook Incorporated
DRE
Jan 6, 2017K162181Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set
Cardiacassist, Inc.
DRE
Aug 11, 2016K161336VSI StraitSet micro-introducer kit
Vascular Solutions, Inc.
DRE
Jul 22, 2016K150932Sheath Introducer
Bioteque Corp., TW
DRE
Jul 8, 2016K161333TightRail Sub-C Rotating Dilator Sheath
Spectranetics, Inc.
DRE
Aug 7, 2015K151877MicroTract Access System
Arstasis, Inc.
DRE
May 22, 2015K151076MicroTaper Needle Introducer Set
Summit Access, LLC
DRE
Mar 4, 2015K150360TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath
Spectranetics, Inc.
DRE
Jan 15, 2015K141070SUPER SHEATH
Togo Medikit Co., Ltd., JP
DRE
Nov 12, 2014K142301Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue
Cook Vascular, Inc.
DRE
Sep 25, 2014K142546TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath
Spectranetics, Inc.
DRE
Jul 1, 2014K141148EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET
Cook Vascular, Inc.
DRE
May 23, 2014K141131TIGHTRAIL MINI
Spectranetics, Inc.
DRE
Apr 9, 2014K140047LEXICONTURE MECHANICAL DILATOR SHEATH SET
Spectranetics Corp.
DRE
Mar 27, 2014K133631LEXIPLIANT DILATOR SHEATH SET
Spectranetics Corporation
DRE
Sep 27, 2013K132713NMI COAXIAL MICROINTRODUCER SET
Navilyst Medical, Inc.
DRE
Jun 24, 2013K123842LAWMAX DILATOR
Lifetech Scientific (Shenzhen) Co., Ltd., CN
DRE
Jun 7, 2013K130791PRELUDE SHEATH INTRODUCER
Merit Medical Systems, Inc.
DRE
Apr 1, 2013K123445NMI COAXIAL MICROINTRODUCER SET
Navilyst Medical, Inc.
DRE
Apr 9, 2012K120349SONIXGPS VASCULAR ACCESS NEEDLE KIT
Ultrasonix Medical Corpation, CA
DRE
May 24, 2011K103421ARSTASIS DILATOR ADAPTER
Arstasis, Inc.
DRE
Apr 13, 2010K093554RETROFLEX DILATOR KIT
Edwards Lifesciences, LLC
DRE
Nov 2, 2009K092378SPECTRANETICS VISISHEATH DILATOR SHEATH
Spectranetics Corp.
DRE
Oct 9, 2009K091584MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE
Merit Medical Systems, Inc.
DRE
Nov 18, 2008K081940AVALON ELITE VASCULAR ACCESS KIT
Avalon Laboratories, LLC
DRE
Aug 15, 2008K082075HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER
Hansen Medical, Inc.
DRE
Nov 20, 2007K073035PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS
Merit Medical Systems, Inc.
DRE
Oct 31, 2007K071330GALTSTICK INTRODUCER SYSTEM
Galt Medical Corp.
DRE
Oct 24, 2007K070749ESTECH PERCUTANEOUS INSERTION DILATOR KIT
Coombs Medical Device Consulting
DRE

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