Dilator, Vessel, For Percutaneous Catheterization

K number K261310

DRE 2025-12-19

ProtekDilate Vascular Access Kit

Applicant Sorin Group Italia S.R.L.

K number K253616

DRE 2025-05-29

VersaCross Connect™ Transseptal Dilator

K number K251325

DRE 2025-01-15

Micro Ace Gold Advanced Micro Access System

K number K242229

DRE 2024-07-12

VersaCross Connect™ Transseptal Dilator

K number K241720

DRE 2023-12-14

VersaCross Connect™ Transseptal Dilator

K number K233647

DRE 2023-09-27

Micro Ace™ Advanced Micro Access System

K number K232609

DRE 2022-12-15

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)

Applicant Spectranetics, Inc.

K number K223472

DRE 2022-08-24

TightRail Guardian Motorized Dilator Sheath

Applicant Spectranetics, Inc.

K number K212784

DRE 2022-02-17

Xtractor device

Applicant Xcardia Innovation , Ltd.

K number K211679

DRE 2021-04-06

Endovascular Dilator and Sets

Applicant Cook Incorporated

K number K210734

DRE 2020-06-12

ExpanSure Large Access Transseptal Dilator

K number K201288

DRE 2020-05-06

MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator

Applicant Medron, LLC

K number K192283

DRE 2020-03-19

Super Sheath

Applicant Togo Medikit Co., Ltd.

K number K200379

DRE 2019-09-26

Sterile Dilator

Applicant Galt Medical Corp.

K number K192195

DRE 2019-04-10

S-MAK XL

K number K190175

DRE 2019-03-21

ExpanSure Transseptal Dilation System

K number K182064

DRE 2018-12-20

Dilator Sets

Applicant Cook Incorporated

K number K183036

DRE 2018-10-29

MC3 Vascular Access Kit 21030

Applicant Mc3 Incorporated

K number K182914

DRE 2017-10-16

Coaxial Dilator Set (Micro-Introducer)

Applicant Galt Medical Corp.

K number K172487

DRE 2017-06-01

Medcomp Vessel Dilator

Applicant Medcomp ( Medical Components)

K number K162389

DRE 2017-04-28

van Andel Dilatation Catheter

Applicant Cook Incorporated

K number K170616

DRE 2017-01-06

Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set

Applicant Cardiacassist, Inc.

K number K162181

DRE 2016-08-11

VSI StraitSet micro-introducer kit

Applicant Vascular Solutions, Inc.

K number K161336

DRE 2016-07-22

Sheath Introducer

Applicant Bioteque Corp.

K number K150932

DRE 2016-07-08

TightRail Sub-C Rotating Dilator Sheath

Applicant Spectranetics, Inc.

K number K161333

DRE 2013-09-27

NMI COAXIAL MICROINTRODUCER SET

Applicant Navilyst Medical, Inc.

K number K132713

DRE 2013-06-24

LAWMAX DILATOR

Applicant Lifetech Scientific (Shenzhen) Co., Ltd.

K number K123842

DRE 2013-06-07

PRELUDE SHEATH INTRODUCER

K number K130791

DRE 2013-04-01

NMI COAXIAL MICROINTRODUCER SET

Applicant Navilyst Medical, Inc.

K number K123445

DRE 2012-04-09

SONIXGPS VASCULAR ACCESS NEEDLE KIT

Applicant Ultrasonix Medical Corpation

K number K120349

DRE 2011-05-24

ARSTASIS DILATOR ADAPTER

Applicant Arstasis, Inc.

K number K103421

DRE 2010-04-13

RETROFLEX DILATOR KIT

Applicant Edwards Lifesciences, LLC

K number K093554

DRE 2009-11-02

SPECTRANETICS VISISHEATH DILATOR SHEATH

Applicant Spectranetics Corp.

K number K092378

DRE 2009-10-09

MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE

K number K091584

DRE 2008-11-18

AVALON ELITE VASCULAR ACCESS KIT

Applicant Avalon Laboratories, LLC

K number K081940

DRE 2008-08-15

HANSEN MEDICAL DILATOR FOR ARTISAN CONTROL CATHETER

Applicant Hansen Medical, Inc.

K number K082075

DRE 2007-11-20

PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS

K number K073035

DRE 2007-10-31

GALTSTICK INTRODUCER SYSTEM

Applicant Galt Medical Corp.

K number K071330

DRE 2007-10-24

ESTECH PERCUTANEOUS INSERTION DILATOR KIT

Applicant Coombs Medical Device Consulting

K number K070749

DRE 2007-06-21

PRELUDE SHEATH INTRODUCER

K number K070159

DRE 2007-02-06

STARCLOSE HEX-HUB DILATOR

Applicant Abbott Vascular, Inc.

K number K062554

DRE 2006-05-10

EVOLUTION MECHANICAL DILATOR SHEATH SET MODELS-LR-EVN-7.0, LR-EVN-9.0

Applicant Cook Vascular, Inc.

K number K061000

DRE 2006-01-17

SUPER SHEATH INTRODUCER SHEATH

Applicant Togo Medikit Co., Ltd.

K number K052557

DRE 2005-05-06

MERIT PRELUDE SHEATH INTRODUCER

K number K050962

DRE 2003-09-03

MERIT MAK (MINI ACCESS KIT)

K number K031691

DRE 2003-02-20

GELBFISH FLEX VASCULAR DILATOR

Applicant Vascumetrix, LLC

K number K030260

DRE 2002-11-08

MODIFICATION TO GELBFISH VASCULAR DILATORS

Applicant Vascumetrix, LLC

K number K023507

DRE 2001-12-20

GELBISH VASCULAR DILATOR

Applicant Vascumetrix, LLC

K number K012256

DRE 2001-06-14

COOK VASCULAR ELECTROSURGICAL DISSECTION SHEATH

Applicant Cook Vascular, Inc.

K number K010055

DRE 2000-08-01

COAXIAL DILATOR SET

Applicant Xentek Medical, Inc.

K number K000737

DRE 1998-12-01

PERIPHERAL VASCULAR DILATOR

Applicant Endovascular Instruments, Inc.

K number K974617

DRE 1998-04-24

URESIL DILATOR WITH RADIOPAQUE MARKER

Applicant Uresil Corp.

K number K980282

DRE 1998-03-13

COAXIAL DILATOR SET

Applicant Boston Scientific Corp

K number K974640

DRE 1997-07-31

EVT EXPANDABLE SHEATH

Applicant Guidant Cardiac and Vascular Surgery

K number K970470

DRE 1997-04-24

CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM

Applicant Cordis Corp.

K number K970392

DRE 1997-04-04

FLEXIBLE DILATING SHEATH

Applicant Med Institute, Inc.

K number K945586

DRE 1997-03-11

VESSEL DILATOR

Applicant Maxxim Medical

K number K963388

DRE 1996-07-02

PERCUGLIDE

Applicant Scientific Device Manufacturer, LLC

K number K960917

DRE 1992-01-03

WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI)

Applicant Med Institute, Inc.

K number K914555

DRE 1991-11-27

VESSEL DILATOR

Applicant Deseret Medical, Inc.

K number K913027

DRE 1991-10-09

NOVOSTE VESSEL DILATER

Applicant Novaste Corp.

K number K912050

DRE 1991-03-25

VESSEL DILATOR

Applicant The R Group

K number K905416

DRE 1990-12-10

VESSEL DILATOR

Applicant Datascope Corp.

K number K904476

DRE 1990-08-23

BYRD DILATOR SHEATH SET - TEFLON

Applicant Medical Engineering and Development Institute

K number K902469

DRE 1990-07-03

MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY

Applicant Pioneering Technologies, Inc.

K number K901815

DRE 1990-04-10

SOLOSTICK (AMPLATZ DILATOR NEEDLE)

Applicant Microvena Corp.

K number K896096

DRE 1989-09-12

DAIG VESSEL DILATOR

Applicant Daig Corp.

K number K894330

DRE 1988-08-25

VESSEL DILATOR AND INTRODUCER SHEATH

Applicant Ideal Medical, Inc.

K number K882238

DRE 1988-06-09

SHILEY FEMORAL CANNULAE INTRODUCER KIT

Applicant Shiley, Inc.

K number K881073

DRE 1988-05-02

10 AND 12 FRENCH VESSEL DILATORS

Applicant Impra, Inc.

K number K874738

DRE 1988-03-25

MODIFIED SELDINGER INITIAL PUNCTURE INSTRUMENT

Applicant Schneider-Shilley (Usa)

K number K875327

DRE 1987-09-15

SHEATH/DILATORS

Applicant Med-West, Inc.

K number K872724

DRE 1987-06-01

PERCUTANEOUS SHEATH W/WO MEDI. (5,6,7,8,8.5FR)

Applicant Medical Surgical Concepts, Inc.

K number K870413

DRE 1987-04-22

URESIL CAROTID ARTERY SIZERS

Applicant Uresil Corp.

K number K871148

DRE 1986-08-19

MODIFICATION OF TISSUE DILATOR

Applicant Quinton, Inc.

K number K862288

DRE 1986-05-02

HEART CATHETERIZATION TRAY

Applicant Medical Design Concepts, Inc.

K number K860161

DRE 1985-02-25

CARDIAC CATHETERIZATION PACK

Applicant Marwood Medical, Inc.

K number K850337

DRE 1984-09-11

ANGIOSYSTEMS STANDARD ARTERIOGRAM & CARD

Applicant Angiosystems, Inc.

K number K843261

DRE 1984-07-13

AMENDMENT TO ANGIOGRAPHY KIT W/ADDIT

Applicant Mallinckrodt Critical Care

K number K842113

DRE 1984-07-02

10.5 FRENCH DILATOR, 15CM, W/LUER LOCK

Applicant Quinton, Inc.

K number K841995

DRE 1984-03-12

CARDIAC CATHETERIZATION PACK

Applicant Professional Medical Services

K number K840671

DRE 1984-02-04

HEART CATHETERIZATION TRAY SET

Applicant Medi-Plast Intl., Inc.

K number K840022

DRE 1984-02-04

VERTEX PERCUTANEOUS CATHETER INTRODUC

Applicant Professional Medical Services

K number K840017

DRE 1983-12-16

8 FRENCH DILATOR 15CM, W/LUER LOCK

Applicant Quinton, Inc.

K number K833965

DRE 1983-05-09

VESSEL DILATOR

Applicant Medrad, Inc.

K number K831190

DRE 1982-09-28

VESSEL DILATOR

Applicant Vertex Medical Corp.

K number K822595

DRE 1981-12-29

PERCUTANEOUS ENTRY NEEDLE, SELDINGER

Applicant Ocean Medical Products, Ltd.

K number K813461

DRE 1981-12-14

MICRO TRANSDUCER CATHETERS

Applicant Honeywell, Inc.

K number K813125

DRE 1981-04-11

SINGLE USE SELDINGER/COURNAND PERC. NDL

Applicant Procedure Products, Inc.

K number K810859

DRE 1980-10-10

SHEATH DILATOR SET

Applicant Stanco Medical, Inc.

K number K802327

DRE 1980-07-28

DILATOR, VESSEL, FOR PERC. CATHETER.

Applicant Alva Medical, Inc.

K number K801113

DRE 1980-03-19

PERCUTANEOUS INTRODUCER SET

Applicant Medical Components, Inc.

K number K800462

DRE 1978-03-02

DILATOR, VESSEL & INTRODUCER, SHEATH

Applicant Argon Medical Corp.

K number K780126

DRE 1976-08-23

TEMPORARY ATRIAL ELECTRODE KIT

Applicant Usci, Div. C.R. Bard, Inc.

K number K760403