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 2013-01-29

HEARTSPAN STEERABLE INTRODUCER KIT

Applicant Thomas Medical Products, Inc.

K number K122431

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DYB 2013-01-28

AXERA 2 ACCESS SYSTEM MODEL AXE200

Applicant Arstasis, Inc.

K number K123135

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DYB 2013-01-24

REPROCESSED STEERABLE INTRODUCER

Applicant Stryker Sustainability Solutions, Inc.

K number K123334

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DYB 2013-01-24

SUREFLEX STEERABLE GUIDING SHEATH KIT

Applicant Baylis Medical Co., Inc.

K number K122926

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DYB 2013-01-04

ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER

Applicant Arrow International (Subsidiary of Teleflex Inc.)

K number K122854

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DYB 2012-12-13

STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO

Applicant Oscor, Inc.

K number K122960

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DYB 2012-12-13

DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY

Applicant Oscor, Inc.

K number K122958

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DYB 2012-12-11

GLIDESHEATH SLENDER MODEL RM* ES6J10HQS, GLIDESHEATH SLENDER MODEL RM* ES6F16HQ, GLIDESHEATH SLENDER MODEL RM * RS6J10PQ

Applicant Terumo Medical Corporation

K number K122980

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DYB 2012-11-20

GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING

Applicant W. L. Gore & Associates, Inc.

K number K121234

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DYB 2012-11-19

PTFE SUPER SHEATH INTRODUCER

Applicant Martech Medical Products

K number K120617

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DYB 2012-09-27

SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS

Applicant Togo Medikit Co., Ltd.

K number K121504

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DYB 2012-08-29

INTRODUCER SET, MODEL ADELANTE-S SERIES

Applicant Oscor, Inc.

K number K122084

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DYB 2012-08-23

LINEBACKER(TM) TRANSSEPTAL INTRODUCER, 53CM / 62CM / 72CM

Applicant Ep Dynamics, Inc.

K number K111603

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DYB 2012-08-22

EDWARDS PERCUTANEOUS SHEATH INTRODUCER

Applicant Edwards Lifesciences, LLC

K number K121185

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DYB 2012-08-17

PRELUDE 7F SHORT SHEATH INTRODUCER

Applicant Merit Medical Systems, Inc.

K number K122190

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DYB 2012-08-14

CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS

Applicant Thomas Medical Products, Inc.

K number K120158

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DYB 2012-07-31

HQS INTRODUCER

Applicant Alseal

K number K113849

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DYB 2012-07-27

THE POWERWAND SAFETY INTRODUCER WITH AND EXTENDED DWELL

Applicant Access Scientific, Inc.

K number K121748

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DYB 2012-06-29

STEERABLE GUIDING SHEATH, MODEL ADELANTE DESTINO

Applicant Oscor, Inc.

K number K120459

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DYB 2012-06-21

AXERA ACCESS SYSTEM

Applicant Arstasis, Inc.

K number K121521

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DYB 2012-04-20

GORE DRYSEAL SHEATH

Applicant W. L. Gore & Associates, Inc.

K number K120428

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DYB 2012-04-12

TRIV(TM) VALVED TEARAWAY INTRODUCER, TIRV(TM) VALVED TEARAWAY INTRODUCER WITH SIDE PORT

Applicant Galt Medical

K number K112398

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DYB 2012-03-21

UPSTREAM NEEDLE HOLDER, UPSTREAM NEEDLE HOLDER WITH SHUT-OFF CONNECTOR

Applicant Upstream Peripheral Technologies

K number K112887

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DYB 2012-02-09

AFX INTRODUCER SYSTEM

Applicant Endologix, Inc.

K number K120212

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DYB 2012-02-09

SMITH MEDICAL PEEL-AWAY SHEATH INTRODUCERS

Applicant Smiths Medical MD, Inc.

K number K112407

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DYB 2012-02-06

VASCULAR SONO

Applicant PAJUNK GmbH Medizintechnologie

K number K113196

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DYB 2012-02-02

RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT

Applicant Great Batch Medical

K number K110051

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DYB 2011-11-18

TRANSRADIAL ARTERY ACCESS DEVICES

Applicant Teleflexmedical, Inc.

K number K112554

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DYB 2011-11-10

NEXGEN EXPANDABLE CATHETER

Applicant Nexgen Medical Systems, Inc.

K number K102925

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DYB 2011-11-09

AXERA ACCESS SYSTEM

Applicant Arstasis, Inc.

K number K113110

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DYB 2011-10-03

PINNACLE PRECISION ACCESS SYSTEM

Applicant Terumo Medical Corp.

K number K111606

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DYB 2011-09-29

AGILLS PF DELIVERY SYSTEM

Applicant St. Jude Medical, Cardiac Rhythm Management Divisi

K number K111943

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DYB 2011-07-15

THE POWERWAND (R) SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

Applicant Access Scientific, Inc.

K number K111417

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DYB 2011-07-12

ENDOLOGIX AFX INTRODUCER SYSTEM

Applicant Endologix, Inc.

K number K111747

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DYB 2011-06-22

THE PICC WAND (R) PEELABLE SAFETY INTRODUCER

Applicant Access Scientific, Inc.

K number K111138

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DYB 2011-06-09

ENGAGE/ENGAGE TR INTRODUCERS

Applicant St Jude Medical

K number K111092

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DYB 2011-05-26

AFX INTRODUCER SYSTEM

Applicant Endologix, Inc.

K number K110090

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DYB 2011-05-10

AGILIS NXT STEERABLE INTRODUCER

Applicant St Jude Medical

K number K110450

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DYB 2011-04-08

AGILIS ES STEERABLE INTRODUCER

Applicant St Jude Medical

K number K103083

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DYB 2011-04-01

TORFLEX TRANSSEPTAL GUIDING SHEATH

Applicant Baylis Medical Co., Inc.

K number K102948

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DYB 2011-03-22

THE POWER WAND SAFETY INTRODUCER WITH AN EXTENDED DWELL CATHETER

Applicant Access Scientific, Inc.

K number K101422

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DYB 2011-02-25

FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815

Applicant Contract Medical Intl. GmbH

K number K100799

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DYB 2011-02-02

ARSTASIS ONE LATCHWIRE ACCESS SYSTEM

Applicant Arstasis, Inc.

K number K103143

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DYB 2011-01-24

VSI MICRO-INTRODUCER SETS (REGULAR, STIFFEN), MODELS 7197V-7209V, 7240V-7256V, 7259V, 7230V, 7231V, 7260V, 7274V

Applicant Vascular Solutions, Inc.

K number K101604

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DYB 2010-11-26

MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX

Applicant Great Batch Medical

K number K101784

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DYB 2010-11-16

PTFE PORTABLE INTRODUCER

Applicant Great Batch Medical

K number K102540

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DYB 2010-10-20

DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY

Applicant Oscor, Inc.

K number K101497

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DYB 2010-10-07

ARSTASIS ACCESS SYSTEM

Applicant Arstasis, Inc.

K number K102728

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DYB 2010-09-07

6F ENGAGE/ENGAGE TR INTRODUCER

Applicant St Jude Medical

K number K101883

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DYB 2010-08-13

PICC WAND PEELABLE SAFETY INTRODUCER

Applicant Access Scientific, Inc.

K number K101150

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DYB 2010-08-02

THE SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER

Applicant Onset Medical Corporation

K number K100819

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DYB 2010-07-21

GLIDESHEATH

Applicant Terumo Medical Corp.

K number K102008

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DYB 2010-07-01

RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26

Applicant Edwards Lifesciences, LLC

K number K093877

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DYB 2010-06-17

COAXIAL INTRODUCER SET

Applicant Martech Medical Products

K number K101399

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DYB 2010-05-06

A.B. KORKOR MEDICAL SKINNYSAFE INTRODUCER SHEATH

Applicant A.B. Korkor Medical, Inc.

K number K092097

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DYB 2010-03-30

ARSTASIS ACCESS SYSTEM

Applicant Arstasis, Inc.

K number K100615

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DYB 2010-03-22

GORE DRYSEAL SHEATH

Applicant W. L. Gore & Associates, Inc.

K number K093791

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DYB 2010-03-15

OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER

Applicant Great Batch Medical

K number K093232

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DYB 2010-02-25

ITG VASCULAR ACCESS SYSTEM, MODEL 300

Applicant Arstasis, Inc.

K number K091006

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DYB 2010-02-24

FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER

Applicant Footprint Medical

K number K093026

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DYB 2010-01-20

THE PICC WAND PEELABLE SAFETY INTRODUCER

Applicant Access Scientific, Inc.

K number K093022

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DYB 2010-01-08

MICRO-STICK SET

Applicant Medcomp

K number K091954

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DYB 2009-11-05

GDS-DCS

Applicant Guided Delivery Systems

K number K091367

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DYB 2009-11-04

ENGAGE TR INTRODUCER

Applicant St Jude Medical

K number K093130

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DYB 2009-10-29

PTFE PEELABLE INTRODUCER

Applicant Great Batch Medical

K number K093023

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DYB 2009-10-08

ENGAGE/ENGAGE TR

Applicant St Jude Medical

K number K092575

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DYB 2009-10-08

SOLOPATH BALLOON EXPANDABLE TRANSFEMORAL INTRODUCER

Applicant Onset Medical Corporation

K number K092014

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DYB 2009-09-01

VALVED TEARWAY INTRODUCER

Applicant Medcomp

K number K090394

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DYB 2009-07-30

AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002

Applicant Ep Dynamics, Inc.

K number K090867

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DYB 2009-06-04

MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S

Applicant Oscor, Inc.

K number K090114

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DYB 2009-05-29

PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH

Applicant Terumo Medical Corp.

K number K091329

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DYB 2009-04-22

ULTIMUM/ENGAGE/ENGAGE TR

Applicant St Jude Medical

K number K091137

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DYB 2009-04-15

BIOCARDIA MORPH SHEATH GUIDE

Applicant Biocardia, Inc.

K number K090999

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DYB 2009-03-30

THE WAND MICROACCESS SAFETY INTRODUCER

Applicant Access Scientific, Inc.

K number K090372

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DYB 2009-02-17

MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59

Applicant Acumen Medical, Inc.

K number K083855

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DYB 2009-02-03

CROSSOVER

Applicant Thomas Medical Products, Inc.

K number K083269

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DYB 2008-12-15

AGILIS NXT STEERABLE INTRODUCER, MODEL G408322 AND G408323

Applicant St Jude Medical

K number K083402

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DYB 2008-12-09

AGILIS NXT STEERABLE INTRODUCER, MODEL G408324

Applicant St Jude Medical

K number K081645

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DYB 2008-12-08

SPECTRA GUIDEWIRE INTRODUCER NEEDLE

Applicant Spectra Medical Devices, Inc.

K number K082580

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DYB 2008-12-04

THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006

Applicant Access Scientific, Inc.

K number K081697

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DYB 2008-11-06

AGILIS NXT STEERABLE INTRODUCER

Applicant St Jude Medical

K number K083083

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DYB 2008-10-29

PINNACLE ROII INTRODUCER SHEATH

Applicant Terumo Medical Corp.

K number K082847

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DYB 2008-10-15

PRELUDE SHORT SHEATH INTRODUCER

Applicant Merit Medical Systems, Inc.

K number K082063

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DYB 2008-09-18

GLIDESHEATH

Applicant Terumo Medical Corp.

K number K082644

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DYB 2008-09-15

PTFE INTERLOCK PEELABLE INTRODUCERS

Applicant Enpath Medical, Inc.

K number K081394

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DYB 2008-08-28

GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

Applicant W. L. Gore & Associates, Inc.

K number K082356

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DYB 2008-05-28

DESTINATION RENAL GUIDING SHEATH

Applicant Terumo Medical Corp.

K number K081045

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DYB 2008-05-21

PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH

Applicant Terumo Medical Corp.

K number K081046

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DYB 2008-05-14

REINFORCED CATHETER INTRODUCER SYSTEM (RCIS)

Applicant Thomas Medical Products, Inc.

K number K081341

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DYB 2008-04-01

BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER

Applicant Bipore, Inc.

K number K073434

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DYB 2008-03-13

MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7

Applicant Acumen Medical, Inc.

K number K080500

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DYB 2008-03-07

DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH

Applicant Terumo Medical Corp.

K number K080415

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DYB 2008-03-07

CONVOY ADVANCED DELIVERY SHEATH

Applicant Boston Scientific Corp

K number K072719

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DYB 2007-11-30

INTRODUCER SETS, MODELS ADELANTE AND ADELANTE-S

Applicant Oscor, Inc.

K number K073100

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DYB 2007-11-09

VIAPEEL PEELABLE INTRODUCER

Applicant Enpath Medical, Inc.

K number K072248

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DYB 2007-10-31

PTFE PEEL AWAY MICROINTRODUCER

Applicant Intromed

K number K072130

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DYB 2007-10-23

EXPANDING VASCULAR SHEATH

Applicant Applied Medical

K number K070865

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DYB 2007-09-19

PERIPHERAL GUIDING SHEATH

Applicant Micrus Design Technology, Inc.

K number K070816

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DYB 2007-09-12

INTRAVASCULAR INTRODUCER SYSTEM

Applicant Applied Medical Resources Corp.

K number K063658

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DYB 2007-07-05

STIFFER COAXIAL MICRO-INTRODUCER KIT

Applicant Enpath Medical, Inc.

K number K071574

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