Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Introducer, Catheter

FDA product code DYB · 659 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1340
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1977-03-16 – 2026-07-29

DYB 2019-12-03

Glidesheath Slender Tibial Pedal Kit

Applicant Terumo Medical Coporation

K number K193160

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DYB 2019-11-18

Impella CP Introducer

Applicant Abiomed, Inc.

K number K192769

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DYB 2019-09-03

AcQRef Introducer Sheath

Applicant Acutus Medical, Inc.

K number K192106

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DYB 2019-08-07

15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set

Applicant Boston Scientific Corporation

K number K191871

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DYB 2019-08-02

Epicardial Access System

Applicant Baylis Medical Company, Inc.

K number K191546

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DYB 2019-08-01

Steerable Introducer

Applicant Freudenberg Medical, LLC

K number K191190

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DYB 2019-07-25

The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model

Applicant Access Scientific, LLC

K number K183066

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DYB 2019-05-30

FlexSeal Introducer Sheath with Hydrophilic Coating

Applicant Freudenberg Medical Mis, Inc.

K number K190628

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DYB 2019-05-20

VersaCross Transseptal Sheath

Applicant Baylis Medical Company, Inc.

K number K183655

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DYB 2019-05-14

D'Vill Introducer

Applicant NuMED, Inc.

K number K190974

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DYB 2019-05-06

BioCardia 8.5 F Avance Steerable lntroducer

Applicant Biocardia, Inc.

K number K190941

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DYB 2019-04-18

Guide Sheath

Applicant Surmodics,Inc.

K number K190644

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DYB 2019-04-17

VersaCross Steerable Sheath, VersaCross Transseptal Dilator

Applicant Baylis Medical Company, Inc.

K number K190688

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DYB 2019-04-17

M-Y Sheath

Applicant Ram Medical Innovations, Inc.

K number K190369

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DYB 2019-03-26

transGlideXT Expandable Introducer

Applicant Transaortic Medical, Inc.

K number K181817

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DYB 2019-03-07

iSLEEVE Introducer Set

Applicant Boston Scientific

K number K190184

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DYB 2019-03-07

Endophys Pressure Sensing Sheath

Applicant Endophys Holdings, LLC

K number K190098

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DYB 2018-12-13

DuraSheath Introducer Sheath System

Applicant Contract Medical International, GmbH

K number K181463

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DYB 2018-10-26

TSI Transseptal Introducer

Applicant Pressure Products Medical Device Manufacturing, LLC

K number K181031

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DYB 2018-10-12

Endophys Pressure Sensing Sheath Kit

Applicant Endophys Holdings, LLC

K number K180620

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DYB 2018-09-28

TSP Crosser Transseptal Access System

Applicant Transseptal Solutions , Ltd.

K number K181088

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DYB 2018-09-18

The CVC WAND Safety Introducer with Valved Peelable Sheath

Applicant Access Scientific, LLC

K number K182243

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DYB 2018-08-15

RAIN Sheath Transradial

Applicant Cordis Corporation

K number K181592

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DYB 2018-08-03

Glidesheath Slender Tibial Pedal Kit

Applicant Terumo Medical Corporation

K number K181237

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DYB 2018-07-26

RadialSeal Introducer Kit

Applicant Great Batch Medical

K number K181855

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DYB 2018-06-22

iSLEEVE Introducer Set

Applicant Boston Scientific Corporation

K number K180785

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DYB 2018-06-04

Check-Flo Performer Introducer Micropuncture Radial Artery Access Set

Applicant Cook Incorporated

K number K171609

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DYB 2018-05-09

VSI Micro-Introducer Kit

Applicant Vascular Solutions, Inc.

K number K180913

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DYB 2018-05-08

Glidesheath Slender

Applicant Terumo Medical Corporation

K number K173831

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DYB 2018-05-03

Micropuncture Pedal Access Set

Applicant Cook Incorporated

K number K172980

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DYB 2018-04-18

RAILWAY Sheathless Access System

Applicant Cordis Corporation

K number K180081

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DYB 2018-03-30

Performer Guiding Sheath

Applicant Cook Incorporated

K number K171988

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DYB 2018-03-09

Transjugular Liver Access Sets

Applicant Cook Incorporated

K number K171820

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DYB 2018-03-02

Type I, Type II, Type III, Type IV

Applicant Lepu Medical Technology (Beijing) Co., Ltd.

K number K172331

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DYB 2018-02-15

Prelude IDeal Hydrophilic Sheath Introducer

Applicant Merit Medical Systems, Inc.

K number K173750

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DYB 2018-02-06

AcQRef Introducer Sheath

Applicant Acutus Medical, Inc.

K number K171557

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DYB 2017-12-21

Elite HV Radial

Applicant Galt Medical Corp.

K number K173287

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DYB 2017-12-20

Peel-Away Introducer Set

Applicant Cook Incorporated

K number K173685

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DYB 2017-12-20

Sentrant Introducer Sheath with Hydrophilic Coating

Applicant Medtronic Vascular, Inc.

K number K171866

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DYB 2017-12-20

Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design

Applicant Cook Incorporated

K number K171275

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DYB 2017-11-30

Endophys Pressure Sensing Sheath Kit- 8F

Applicant Endophys Holdings, LLC

K number K173399

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DYB 2017-11-21

Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath

Applicant Terumo Medical Corporation

K number K172995

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DYB 2017-11-17

Performer Introducer

Applicant Cook Incorporated

K number K173068

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DYB 2017-10-20

D'Vill Introducer

Applicant NuMED, Inc.

K number K171206

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DYB 2017-10-05

Shoocin Introducer Kit

Applicant Lepu Medical Technology (Beijing) Co., Ltd.

K number K172099

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DYB 2017-10-05

R2P Destination Slender Guiding Sheath

Applicant Terumo Medical Corporation

K number K171491

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DYB 2017-09-28

Peel-Away Introducer Set

Applicant Cook Incorporated

K number K170020

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DYB 2017-09-11

Prelude Pursuit Splittable Sheath Introducer

Applicant Merit Medical Systems, Inc.

K number K172117

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DYB 2017-08-24

Liver Access and Biopsy Sets

Applicant Cook Incorporated

K number K171853

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DYB 2017-07-31

Performer Introducer

Applicant Cook Incorporated

K number K171999

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DYB 2017-07-25

CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath

Applicant Biosense Webster, Inc.

K number K170997

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DYB 2017-07-19

Mini Stick ENVI Non-Vascular Introducer Kit

Applicant AngioDynamics, Inc.

K number K170775

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DYB 2017-05-30

VenaCure EVLT NeverTouch Direct Introducer Sheath

Applicant AngioDynamics, Inc.

K number K170695

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DYB 2017-05-09

Guider Catheter Introducer

Applicant Rhythm Xience, Inc. (Rxi)

K number K171081

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DYB 2017-05-09

EpiAccess System

Applicant Epiep, Inc.

K number K170831

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DYB 2017-04-05

HeartSpan Steerable Sheath Introducer

Applicant Merit Medical Systems, Inc.

K number K170668

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DYB 2017-03-07

Vado Steerable Sheath

Applicant Kalila Medical, Inc.

K number K160721

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DYB 2017-02-27

Flextra Steerable Introducer

Applicant Rhythm Xience, Inc. (Rxi)

K number K170373

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DYB 2017-02-02

FlexCath Select Steerable Shealth and Dilator

Applicant Medtronic Cryocath, LP

K number K163268

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DYB 2017-01-27

Vado Bi-Directional Steerable Sheath

Applicant Kalila Medical, Inc.

K number K162427

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DYB 2016-11-17

the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. Model

Applicant Access Scientific, LLC

K number K162322

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DYB 2016-11-17

InTRAkit

Applicant Medtronic Vascular

K number K162097

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DYB 2016-11-04

Pinpoint GT Introducer Needle

Applicant C.R. Bard, Inc.

K number K162769

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DYB 2016-09-13

TXM Guiding Sheath

Applicant Texasmedical Technologies, Inc.

K number K153771

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DYB 2016-09-02

Edwards eSheath Introducer Set

Applicant Edward Lifesciences

K number K162184

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DYB 2016-08-25

HQS Introducer (Model 2064-HQS)

Applicant Alseal

K number K153494

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DYB 2016-07-21

GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle

Applicant Creganna Medical Aslo Business AS Cregganna Tactx Medical

K number K152913

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DYB 2016-07-15

FlexSeal Introducer Sheath with Hydrophilic Coating

Applicant Libramedical, Inc.

K number K161659

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DYB 2016-07-05

Tearaway Introducer Sheath, MicroSlide Tearaway Introducer

Applicant Galt Medical Corp.

K number K153533

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DYB 2016-06-03

Halo One Thin-Walled Guiding Sheath

Applicant C.R. Bard, Inc.

K number K161183

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DYB 2016-05-19

Nanostim Introducer Kit

Applicant St. Jude Medical, Inc.

K number K161102

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DYB 2016-05-12

GORE DrySeal Flex Introducer Sheath

Applicant W. L. Gore & Associates, Inc.

K number K160254

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DYB 2016-04-14

The Nanostim Introducer Kit

Applicant St. Jude Medical, Inc.

K number K160716

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DYB 2016-04-07

transGlide Expandable Introducer

Applicant Transaortic Medical, Inc.

K number K152194

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DYB 2016-03-07

Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select

Applicant Cook Incorporated

K number K153430

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DYB 2016-03-04

Endophys Pressure Sensing Sheath Kit

Applicant Endophys, Inc.

K number K160272

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DYB 2016-02-12

PTFE Super Sheath Introducer 2.1

Applicant Medcomp (Medical Components, Inc.)

K number K153246

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DYB 2016-01-11

Fortress Introducer Sheath SYstem

Applicant Contract Medical International, GmbH

K number K153197

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DYB 2016-01-05

SoloPath Re-Collapsible Access System

Applicant Onset Medical Corporation

K number K152498

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DYB 2013-11-25

VALVED TEARAWAY INTRODUCER GENERATION II

Applicant Medcomp (Medical Components, Inc.)

K number K132498

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DYB 2013-11-22

V-STICK VASCULAR ACCESS SET

Applicant Argon Medical

K number K130730

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DYB 2013-09-27

MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING

Applicant Medtronic, Inc.

K number K132030

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DYB 2013-09-17

HEARTSPAN STEERABLE INTRODUCER KIT

Applicant Merit Medical Systems, Inc.

K number K132164

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DYB 2013-09-04

THE CVC WAND SAFETY INTRODUCER WITH VALVED PEELABLE SHEATH

Applicant Access Scientific, LLC

K number K131148

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DYB 2013-08-19

AXERA 2 ACCESS SYSTEM

Applicant Arstasis, Inc.

K number K132263

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DYB 2013-08-15

AMECO SHEATH INTRODUCER

Applicant Ameco Medical Industries

K number K131144

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DYB 2013-08-15

2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER

Applicant Medical Components, Inc.

K number K130687

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DYB 2013-08-01

CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC

Applicant Creganna Medical Devices

K number K131079

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DYB 2013-07-29

PTFE SUPER SHEATH INTRODUCER

Applicant Martech Medical Products

K number K130855

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DYB 2013-07-24

EDWARDS EMBOL-X INTRODUCER SHEATH

Applicant Edwards Lifesciences, LLC

K number K123714

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DYB 2013-07-19

CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER

Applicant Cardiosolutions, Inc.

K number K131332

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DYB 2013-06-07

THE POWERWAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

Applicant Access Scientific, LLC

K number K131300

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DYB 2013-06-03

VALVED TEARAWAY INTRODUCER GENERATION II

Applicant Medical Components, Inc.

K number K124046

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DYB 2013-05-24

MOBICATH BI-DIRECTIONAL GUIDING SHEATH

Applicant Great Batch Medical

K number K130559

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DYB 2013-05-03

SOLOPATH RE-COLLAPSIBLE ACCESS SYSTEM

Applicant Onset Medical Corporation

K number K121404

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DYB 2013-04-26

SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING

Applicant Medtronic Vascular

K number K123990

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DYB 2013-04-12

MICROSLIDER TEARAWAY INTRODUCER SET

Applicant Galt Medical Corp.

K number K123430

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DYB 2013-03-24

AXERA 2 ACCESS SYSTEM

Applicant Arstasis, Inc.

K number K123618

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DYB 2013-02-21

PERCUTANEOUS INTRODUCER KIT

Applicant Teleflex, Inc.

K number K123974

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DYB 2013-02-14

EQUAFLOW MULTIVALVE INFUSION CATHETER

Applicant Cook Incorporated

K number K123235

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