Product Code: DRE
FDA class 2
21 CFR 870.1310
Dilator, Vessel, For Percutaneous Catheterization
Cardiovascular
The Vessel Dilator for Percutaneous Catheterization is a cardiovascular device used to progressively enlarge a puncture site in a blood vessel, allowing passage of a catheter or introducer sheath during percutaneous access procedures. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DRE and it is regulated under 21 CFR 870.1310 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.
510(k)s
103
FEI Numbers
97
Registration Numbers
97
Unique Applicants
72
Years Active
49
Basic Information
- Product Code
- DRE
- Device Class
- FDA class 2
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✓
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 103 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K251325 | VersaCross Connect Transseptal Dilator | May 29, 2025 | Substantially Equivalent | Baylis Medical Company Inc. |
| K242229 | Micro Ace Gold Advanced Micro Access System | Jan 15, 2025 | Substantially Equivalent | Merit Medical Systems, Inc. |
| K241720 | VersaCross Connect Transseptal Dilator | Jul 12, 2024 | Substantially Equivalent | Baylis Medical Company Inc. |
| K233647 | VersaCross Connect Transseptal Dilator | Dec 14, 2023 | Substantially Equivalent | Baylis Medical Company Inc. |
| K232609 | Micro Ace Advanced Micro Access System | Sep 27, 2023 | Substantially Equivalent | Merit Medical Systems, Inc. |
| 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) | Dec 15, 2022 | Substantially Equivalent | Spectranetics Inc. |
| K212784 | TightRail Guardian Motorized Dilator Sheath | Aug 24, 2022 | Substantially Equivalent | Spectranetics, Inc. |
| K211679 | Xtractor device | Feb 17, 2022 | Substantially Equivalent | Xcardia Innovation Ltd. |
| K210734 | Endovascular Dilator and Sets | Apr 06, 2021 | Substantially Equivalent | Cook Incorporated |
| K201288 | ExpanSure Large Access Transseptal Dilator | Jun 12, 2020 | Substantially Equivalent | Baylis Medical Company Inc. |
| K192283 | MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator | May 06, 2020 | Substantially Equivalent | Medron, LLC |
| K200379 | Super Sheath | Mar 19, 2020 | Substantially Equivalent | TOGO MEDIKIT CO., LTD. |
| K192195 | Sterile Dilator | Sep 26, 2019 | Substantially Equivalent | Galt Medical Corp. |
| K190175 | S-MAK XL | Apr 10, 2019 | Substantially Equivalent | Merit Medical Systems Inc. |
| K182064 | ExpanSure Transseptal Dilation System | Mar 21, 2019 | Substantially Equivalent | Baylis Medical Company Inc. |
| K183036 | Dilator Sets | Dec 20, 2018 | Substantially Equivalent | Cook Incorporated |
| K182914 | MC3 Vascular Access Kit 21030 | Oct 29, 2018 | Substantially Equivalent | MC3 Incorporated |
| K172487 | Coaxial Dilator Set (Micro-Introducer) | Oct 16, 2017 | Unknown | Galt Medical Corp. |
| K162389 | Medcomp Vessel Dilator | Jun 01, 2017 | Substantially Equivalent | MEDCOMP ( MEDICAL COMPONENTS) |
| K170616 | van Andel Dilatation Catheter | Apr 28, 2017 | Substantially Equivalent | Cook Incorporated |
| K162181 | Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set | Jan 06, 2017 | Substantially Equivalent | CARDIACASSIST INC. |
| K161336 | VSI StraitSet micro-introducer kit | Aug 11, 2016 | Substantially Equivalent | VASCULAR SOLUTIONS, INC. |
| K150932 | Sheath Introducer | Jul 22, 2016 | Substantially Equivalent | BIOTEQUE CORP. |
| K161333 | TightRail Sub-C Rotating Dilator Sheath | Jul 08, 2016 | Substantially Equivalent | Spectranetics, Inc. |
| K151877 | MicroTract Access System | Aug 07, 2015 | Substantially Equivalent | ARSTASIS, INC. |
| K151076 | MicroTaper Needle Introducer Set | May 22, 2015 | Substantially Equivalent | Summit Access, LLC |
| K150360 | TightRail Rotating Dilator Sheath, TightRail Mini Rotating Dilator Sheath | Mar 04, 2015 | Substantially Equivalent | SPECTRANETICS, INC. |
| K141070 | SUPER SHEATH | Jan 15, 2015 | Substantially Equivalent | TOGO MEDIKIT CO., LTD. |
| K142301 | Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath Set, SteadySheath Evolution Tissue Stabilization Sheath, SteadySheath Evolution Shortie Tissue Stabilization Sheath | Nov 12, 2014 | Substantially Equivalent | COOK VASCULAR, INC. |
| K142546 | TightRail Rotating Dilator Sheath/TightRail Mini Dilator Sheath | Sep 25, 2014 | Substantially Equivalent | SPECTRANETICS, INC. |
| K141148 | EVOLUTION RL CONTROLLED-ROTATION DILATOR SHEATH SET, EVOLUTION SHORTIE RL CONTROLLED-ROTATION DILATOR SHEATH SET | Jul 01, 2014 | Substantially Equivalent | COOK VASCULAR, INC. |
| K141131 | TIGHTRAIL MINI | May 23, 2014 | Substantially Equivalent | SPECTRANETICS, INC. |
| K140047 | LEXICONTURE MECHANICAL DILATOR SHEATH SET | Apr 09, 2014 | Substantially Equivalent | SPECTRANETICS CORP. |
| K133631 | LEXIPLIANT DILATOR SHEATH SET | Mar 27, 2014 | Substantially Equivalent | SPECTRANETICS CORPORATION |
| K132713 | NMI COAXIAL MICROINTRODUCER SET | Sep 27, 2013 | Substantially Equivalent | NAVILYST MEDICAL, INC. |
| K123842 | LAWMAX DILATOR | Jun 24, 2013 | Substantially Equivalent | LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. |
| K130791 | PRELUDE SHEATH INTRODUCER | Jun 07, 2013 | Substantially Equivalent | MERIT MEDICAL SYSTEMS, INC. |
| K123445 | NMI COAXIAL MICROINTRODUCER SET | Apr 01, 2013 | Substantially Equivalent | NAVILYST MEDICAL, INC. |
| K120349 | SONIXGPS VASCULAR ACCESS NEEDLE KIT | Apr 09, 2012 | Substantially Equivalent | ULTRASONIX MEDICAL CORPATION |
| K103421 | ARSTASIS DILATOR ADAPTER | May 24, 2011 | Substantially Equivalent | ARSTASIS, INC. |
| K093554 | RETROFLEX DILATOR KIT | Apr 13, 2010 | Substantially Equivalent | EDWARDS LIFESCIENCES, LLC. |
| K092378 | SPECTRANETICS VISISHEATH DILATOR SHEATH | Nov 02, 2009 | Substantially Equivalent | SPECTRANETICS CORP. |
| K091584 | MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE | Oct 09, 2009 | Substantially Equivalent | MERIT MEDICAL SYSTEMS, INC. |
| K081940 | AVALON ELITE VASCULAR ACCESS KIT | Nov 18, 2008 | Substantially Equivalent | AVALON LABORATORIES, LLC |
| K082075 | HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER | Aug 15, 2008 | Substantially Equivalent | HANSEN MEDICAL, INC. |
| K073035 | PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS | Nov 20, 2007 | Substantially Equivalent | MERIT MEDICAL SYSTEMS, INC. |
| K071330 | GALTSTICK INTRODUCER SYSTEM | Oct 31, 2007 | Substantially Equivalent | GALT MEDICAL CORP. |
| K070749 | ESTECH PERCUTANEOUS INSERTION DILATOR KIT | Oct 24, 2007 | Substantially Equivalent | COOMBS MEDICAL DEVICE CONSULTING |
| K070159 | PRELUDE SHEATH INTRODUCER | Jun 21, 2007 | Substantially Equivalent | MERIT MEDICAL SYSTEMS, INC. |
| K062554 | STARCLOSE HEX-HUB DILATOR | Feb 06, 2007 | Substantially Equivalent | ABBOTT VASCULAR INC. |
| K061000 | EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0 | May 10, 2006 | Substantially Equivalent | COOK VASCULAR, INC. |
| K052557 | SUPER SHEATH INTRODUCER SHEATH | Jan 17, 2006 | Substantially Equivalent | TOGO MEDIKIT CO., LTD. |
| K050962 | MERIT PRELUDE SHEATH INTRODUCER | May 06, 2005 | Substantially Equivalent | MERIT MEDICAL SYSTEMS, INC. |
| K031691 | MERIT MAK (MINI ACCESS KIT) | Sep 03, 2003 | Substantially Equivalent | MERIT MEDICAL SYSTEMS, INC. |
| K030260 | GELBFISH FLEX VASCULAR DILATOR | Feb 20, 2003 | Substantially Equivalent | VASCUMETRIX, LLC |
| K023507 | MODIFICATION TO GELBFISH VASCULAR DILATORS | Nov 08, 2002 | Substantially Equivalent | VASCUMETRIX, LLC |
| K012256 | GELBISH VASCULAR DILATOR | Dec 20, 2001 | Substantially Equivalent | VASCUMETRIX, LLC |
| K010055 | COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH | Jun 14, 2001 | Substantially Equivalent | COOK VASCULAR, INC. |
| K000737 | COAXIAL DILATOR SET | Aug 01, 2000 | Substantially Equivalent | XENTEK MEDICAL, INC. |
| K974617 | PERIPHERAL VASCULAR DILATOR | Dec 01, 1998 | Substantially Equivalent | ENDOVASCULAR INSTRUMENTS, INC. |
| K980282 | URESIL DILATOR WITH RADIOPAQUE MARKER | Apr 24, 1998 | Substantially Equivalent | URESIL CORP. |
| K974640 | COAXIAL DILATOR SET | Mar 13, 1998 | Substantially Equivalent | BOSTON SCIENTIFIC CORP. |
| K970470 | EVT EXPANDABLE SHEATH | Jul 31, 1997 | Substantially Equivalent | GUIDANT CARDIAC AND VASCULAR SURGERY |
| K970392 | CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM | Apr 24, 1997 | Substantially Equivalent | CORDIS CORP. |
| K945586 | FLEXIBLE DILATING SHEATH | Apr 04, 1997 | Substantially Equivalent | MED INSTITUTE, INC. |
| K963388 | VESSEL DILATOR | Mar 11, 1997 | Substantially Equivalent | MAXXIM MEDICAL |
| K960917 | PERCUGLIDE | Jul 02, 1996 | Substantially Equivalent | SCIENTIFIC DEVICE MANUFACTURER LLC. |
| K914555 | WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI) | Jan 03, 1992 | Substantially Equivalent | MED INSTITUTE, INC. |
| K913027 | VESSEL DILATOR | Nov 27, 1991 | Substantially Equivalent | DESERET MEDICAL, INC. |
| K912050 | NOVOSTE VESSEL DILATER | Oct 09, 1991 | Substantially Equivalent | NOVASTE CORP. |
| K905416 | VESSEL DILATOR | Mar 25, 1991 | Substantially Equivalent | THE R GROUP |
| K904476 | VESSEL DILATOR | Dec 10, 1990 | Substantially Equivalent | DATASCOPE CORP. |
| K902469 | BYRD DILATOR SHEATH SET - TEFLON | Aug 23, 1990 | Substantially Equivalent | MEDICAL ENGINEERING AND DEVELOPMENT INSTITUTE |
| K901815 | MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY | Jul 03, 1990 | Substantially Equivalent | PIONEERING TECHNOLOGIES, INC. |
| K896096 | SOLOSTICK (AMPLATZ DILATOR NEEDLE) | Apr 10, 1990 | Substantially Equivalent | MICROVENA CORP. |
| K894330 | DAIG VESSEL DILATOR | Sep 12, 1989 | Substantially Equivalent | DAIG CORP. |
| K882238 | VESSEL DILATOR AND INTRODUCER SHEATH | Aug 25, 1988 | Substantially Equivalent | IDEAL MEDICAL, INC. |
| K881073 | SHILEY FEMORAL CANNULAE INTRODUCER KIT | Jun 09, 1988 | Substantially Equivalent | SHILEY, INC. |
| K874738 | 10 AND 12 FRENCH VESSEL DILATORS | May 02, 1988 | Substantially Equivalent | IMPRA, INC. |
| K875327 | MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT | Mar 25, 1988 | Substantially Equivalent | SCHNEIDER-SHILLEY (USA) |
| K872724 | SHEATH/DILATORS | Sep 15, 1987 | Substantially Equivalent | MED-WEST, INC. |
| K870413 | PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR) | Jun 01, 1987 | Substantially Equivalent | MEDICAL SURGICAL CONCEPTS, INC. |
| K871148 | URESIL CAROTID ARTERY SIZERS | Apr 22, 1987 | Substantially Equivalent | URESIL CORP. |
| K862288 | MODIFICATION OF TISSUE DILATOR | Aug 19, 1986 | Substantially Equivalent | QUINTON, INC. |
| K860161 | HEART CATHETERIZATION TRAY | May 02, 1986 | Substantially Equivalent | MEDICAL DESIGN CONCEPTS, INC. |
| K850337 | CARDIAC CATHETERIZATION PACK | Feb 25, 1985 | Substantially Equivalent | MARWOOD MEDICAL, INC. |
| K843261 | ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD | Sep 11, 1984 | Substantially Equivalent | ANGIOSYSTEMS, INC. |
| K842113 | AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT | Jul 13, 1984 | Substantially Equivalent | MALLINCKRODT CRITICAL CARE |
| K841995 | 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK | Jul 02, 1984 | Substantially Equivalent | QUINTON, INC. |
| K840671 | CARDIAC CATHETERIZATION PACK | Mar 12, 1984 | Substantially Equivalent | PROFESSIONAL MEDICAL SERVICES |
| K840022 | HEART CATHETERIZATION TRAY SET | Feb 04, 1984 | Substantially Equivalent | MEDI-PLAST INTL., INC. |
| K840017 | VERTEX PERCUTANEOUS CATHETER INTRODUC | Feb 04, 1984 | Substantially Equivalent | PROFESSIONAL MEDICAL SERVICES |
| K833965 | 8 FRENCH DILATOR 15CM, W/LUER LOCK | Dec 16, 1983 | Substantially Equivalent | QUINTON, INC. |
| K831190 | VESSEL DILATOR | May 09, 1983 | Substantially Equivalent | MEDRAD, INC. |
| K822595 | VESSEL DILATOR | Sep 28, 1982 | Substantially Equivalent | VERTEX MEDICAL CORP. |
| K813461 | PERCUTANEOUS ENTRY NEEDLE, SELDINGER | Dec 29, 1981 | Substantially Equivalent | OCEAN MEDICAL PRODUCTS, LTD. |
| K813125 | MICRO TRANSDUCER CATHETERS | Dec 14, 1981 | Substantially Equivalent | HONEYWELL, INC. |
| K810859 | SINGLE USE SELDINGER/COURNAND PERC. NDL | Apr 11, 1981 | Substantially Equivalent | PROCEDURE PRODUCTS, INC. |
| K802327 | SHEATH DILATOR SET | Oct 10, 1980 | Substantially Equivalent | STANCO MEDICAL, INC. |
| K801113 | DILATOR, VESSEL, FOR PERC. CATHETER. | Jul 28, 1980 | Substantially Equivalent | ALVA MEDICAL, INC. |
| K800462 | PERCUTANEOUS INTRODUCER SET | Mar 19, 1980 | Substantially Equivalent | MEDICAL COMPONENTS, INC. |
| K780126 | DILATOR, VESSEL & INTRODUCER, SHEATH | Mar 02, 1978 | Substantially Equivalent | ARGON MEDICAL CORP. |
| K760403 | TEMPORARY ATRIAL ELECTRODE KIT | Aug 23, 1976 | Substantially Equivalent | USCI, DIV. C.R. BARD, INC. |
FEI Numbers
This FDA classification entry is associated with 97 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 97 registration numbers. Click on an entry to view related FDA registrations.