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 2007-06-05

ACROSS TRANSSEPTAL ACCESS SYSTEM, 406977, 406978, 406979, 406980, 406981, 406982, 406983, 406984

Applicant St Jude Medical

K number K070417

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DYB 2007-05-22

MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45

Applicant Acumen Medical, Inc.

K number K070396

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DYB 2007-04-06

STRADA CAROTID GUIDING SHEATH

Applicant St Jude Medical

K number K070166

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DYB 2007-02-23

ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY

Applicant Acumen Medical, Inc.

K number K070197

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DYB 2007-02-23

BALLOON EXPANDABLE TRANSSEPTAL INDRODUCER, MODELS BETI-1840 AND BETI-1870

Applicant Onset Medical Corporation

K number K062852

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DYB 2006-12-21

ENPATH MEDICAL VIASEAL VALVED PEELABLE INTRODUCER, MODEL 10866-XXX

Applicant Enpath Medical, Inc.

K number K063182

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DYB 2006-10-23

MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH

Applicant Terumo Medical Corp.

K number K062446

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DYB 2006-10-20

MODIFICATION TO GLIDESHEATH

Applicant Terumo Medical Corp.

K number K062858

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DYB 2006-08-23

MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90

Applicant Acumen Medical, Inc.

K number K062145

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DYB 2006-08-03

FAST-CATH HEMOSTASIS INTRODUCER AND TRANSSEPTAL INTRODUCER

Applicant St Jude Medical

K number K061015

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DYB 2006-08-01

MEDCOMP VASCU-SHEATH II

Applicant Medcomp

K number K053092

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DYB 2006-07-12

AGILIS NXT STEERABLE INTRODUCER

Applicant St Jude Medical

K number K061363

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DYB 2006-07-07

STARCLOSE INTRODUCER SET MODEL- 1002

Applicant Abbott Vascular, Inc.

K number K060902

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DYB 2006-06-29

CAROTID ACCESS KIT

Applicant Terumo Medical Corp.

K number K060666

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DYB 2006-06-19

ACUMEN SINGLE-LUMEN DELIVERY SHEATH

Applicant Acumen Medical, Inc.

K number K053400

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DYB 2006-05-05

INTRODUCER ASSEMBLY WITH ROTATOR LOCK

Applicant Teleflex Medical

K number K060519

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DYB 2006-04-04

SUPER SHEATH XL INTRODUCER SHEATH

Applicant Togo Medikit Co., Ltd.

K number K060190

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DYB 2005-12-07

BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER

Applicant Bipore, Inc.

K number K051513

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DYB 2005-12-05

SWARTZ BRAIDED TRANSSEPTAL GUIDING INTRODUCER

Applicant St Jude Medical

K number K052644

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DYB 2005-10-27

VYGON MICRO-ACCESS SAFETY INTRODUCER KIT

Applicant Vygon Corp.

K number K051248

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DYB 2005-09-06

DESTINATION CAROTID GUIDING SHEATH

Applicant Terumo Medical Corp.

K number K052185

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DYB 2005-09-01

MODIFIED ACUMEN SHEATH, MODEL TTW 10-65

Applicant Acumen Medical, Inc.

K number K051515

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DYB 2005-08-04

PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH

Applicant Terumo Medical Corp.

K number K051601

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DYB 2005-08-04

INNER-LOCK INTRODUCER SHEATH

Applicant Rex Medical

K number K051468

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DYB 2005-05-17

APEEL CS PLUS CATHETER DELIVERY SYSTEM, MODELS 407579, 407580, 407581, 407582

Applicant St. Jude Medical, Daig Division, Inc.

K number K051096

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DYB 2005-05-02

PREMERE DELIVERY SHEATH, MODEL PDS

Applicant Velocimed, Inc.

K number K043084

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DYB 2005-02-18

SECURELOC; ADVANCINTRODUCER

Applicant Specialized Health Products, Inc.

K number K050023

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DYB 2005-02-17

SHEATH-IN-SHEATH CATHETER, 18FR, MODEL S00018; SHEATH-IN-SHEATH CATHETER, 6 FR., MODEL S00019

Applicant Facile Medical, Inc.

K number K042308

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DYB 2005-02-15

LARGE BORE SPLITTABLE INTRODUCER KIT

Applicant Thomas Medical Products, Inc.

K number K043438

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DYB 2005-02-09

CATHETER INTRODUCER

Applicant Galt Medical Corp.

K number K043525

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DYB 2005-02-03

MODIFIED ACUMEN SHEATH, MODEL TTWO767

Applicant Acumen Medical, Inc.

K number K050015

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DYB 2005-01-27

AGILIS STEERABLE CATHETER INTRODUCER, MODEL 408304

Applicant St. Jude Medical, Daig Division, Inc.

K number K042623

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DYB 2004-12-17

MODIFICATION TO SHORT INTRODUCER SHEATH

Applicant Rex Medical, L.P.

K number K042399

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DYB 2004-11-30

ENPATH SAFETY INTRODUCER

Applicant Enpath Medical Incorporated

K number K041708

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DYB 2004-10-26

ACUMEN SHEATH, MODEL TTW7807

Applicant Acumen Medical, Inc.

K number K042376

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DYB 2004-10-15

INTRAVASCULAR ACCESS INTRODUCER SHEATH

Applicant Applied Medical Resources Corp.

K number K041506

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DYB 2004-08-23

AIRGUARD VALVED INTRODUCER

Applicant C.R. Bard, Inc.

K number K042036

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DYB 2004-06-18

ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND ELVS PROCEDURE KIT

Applicant AngioDynamics, Inc.

K number K040728

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DYB 2004-06-01

MODIFICATION TO BRAIDED GUIDING INTRODUCER SYSTEM

Applicant Thomas Medical Products, Inc.

K number K040713

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DYB 2004-05-28

MODEL 3100 SERIES SHEATH INTRODUCER KITS, MODELS 3110, 3130

Applicant Cryocor, Inc.

K number K040552

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DYB 2004-04-05

SAFETYNET GUIDEWIRE INTRODUCER

Applicant Injectimed, Inc.

K number K040029

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DYB 2004-03-26

NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC

Applicant Nmt Medical, Inc.

K number K034025

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DYB 2004-02-18

MODIFICATION TO MEDAMICUS FLOWGUARD PEELABLE INTRODUCER

Applicant Medamicus, Inc.

K number K040150

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DYB 2004-02-05

INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER

Applicant B.Braun Medical, Inc.

K number K033527

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DYB 2004-01-30

MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH

Applicant Boston Scientific Corp

K number K034061

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DYB 2003-12-11

GLIDESHEATH

Applicant Terumo Corp.

K number K033681

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DYB 2003-10-01

CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W

Applicant Merit Medical Systems, Inc.

K number K031922

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DYB 2003-09-16

SHORT INTRODUCER SHEATH

Applicant Rex Medical

K number K032569

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DYB 2003-09-10

SELDINGER SAFETY NEEDLE INTRODUCER

Applicant Hdc Corp.

K number K032404

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DYB 2003-09-10

PATHWAY ACCESS SHEATH CATHETER

Applicant Vertelink Corporation

K number K030734

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DYB 2003-08-13

GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE

Applicant W. L. Gore & Associates, Inc.

K number K032073

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DYB 2003-07-18

APEEL CS CATHETER DELIVERY SYSTEM

Applicant St Jude Medical

K number K031906

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DYB 2003-07-15

SAFETY INTRODUCER NEEDLE

Applicant B.Braun Medical, Inc.

K number K030135

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DYB 2003-06-20

EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL

Applicant Edwards Lifesciences, LLC

K number K030944

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DYB 2003-06-16

MODIFICATION TO IVS INTRODUCER SET, MODEL 1003

Applicant Integrated Vascular Systems, Inc.

K number K031583

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DYB 2003-05-27

COOK VASCULAR SERPENTA CORONARY SINUS INTRODUCER SYSTEM

Applicant Cook Vascular, Inc.

K number K023937

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DYB 2003-04-24

EDWARDS INTRODUCER SHEATH

Applicant Edwards Lifesciences, LLC

K number K031087

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DYB 2003-04-09

MEDAMICUS FLOWGUARD PEELABLE INTRODUCER

Applicant Medamicus, Inc.

K number K030905

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DYB 2003-04-03

IVS INTRODUCER SET, MODEL 1003

Applicant Integrated Vascular Systems, Inc.

K number K030723

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DYB 2003-01-21

INNER-LOCK LOCKING INTRODUCER SHEATHS

Applicant Rex Medical

K number K022170

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DYB 2002-11-06

CO-AXIAL INTRODUCER NEEDLE

Applicant Promex, Inc.

K number K022634

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DYB 2002-10-31

MODIFICATION TO ULTIMUM EV HEMOSTASIS INTRODUCER (22F)

Applicant St Jude Medical

K number K023447

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DYB 2002-10-25

MEDCOMP VASCU-SHEATH INTRODUCER SET

Applicant Medcomp

K number K022513

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DYB 2002-10-11

NEICH NM ADVANCE CATHETER SHEATH INTRODUCER

Applicant Neich Medical(Shenzhen)Company, Ltd.

K number K020964

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DYB 2002-09-13

TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305

Applicant Micro Therapeutics, Inc.

K number K022003

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DYB 2002-08-23

MODIFICATION TO MEDAMICUS AXIA RSN

Applicant Medamicus, Inc.

K number K022689

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DYB 2002-08-08

SHEATH ADAPTER, MODEL SA-09847

Applicant Arrow Intl., Inc.

K number K021723

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DYB 2002-07-03

INTROCAN SAFETY IV CATHETER

Applicant B.Braun Medical, Inc.

K number K021094

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DYB 2002-06-12

BD INTROSYTE PRECISION INTRODUCER; BD INTROSYTE-N PRECISION INTRODUCER; BD INTROSYTE AUTOGUARD SHIELDED INTRODUCER; BD I

Applicant Becton Dickinson Infusion Therapy Systems, Inc.

K number K020834

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DYB 2002-06-06

VALVED PEELABLE INTRODUCER

Applicant Medamicus, Inc.

K number K021004

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DYB 2002-05-21

MEDAMICUS AXIA RSN

Applicant Medamicus, Inc.

K number K020563

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DYB 2002-04-25

COOK VASCULAR PEEL-AWAY HEMOSTASIS VALVE

Applicant Cook Vascular, Inc.

K number K010128

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DYB 2002-03-08

EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL

Applicant Edwards Lifesciences, LLC

K number K014052

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DYB 2002-02-11

MODIFICATION TO TRANSSEPTAL INTRODUCER SET

Applicant Thomas Medical Products, Inc.

K number K020090

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DYB 2002-01-24

ANCURE SHEATH MODEL # 40315, 40320, 40325

Applicant Guidant Cardiac and Vascular Surgery

K number K003889

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DYB 2001-11-21

RENAL GUIDING SHEATH

Applicant Terumo Medical Corp.

K number K012854

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DYB 2001-11-14

CAROTID GUIDING SHEATH

Applicant Terumo Medical Corp.

K number K012812

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DYB 2001-10-31

MAC TWO-LUMEN CENTRAL VENOUS KIT WITH ARROWG ARD BLUE ANTIMICROBIAL SURFACE AND INTEGRAL HEMOSTASIS VALVE/SIDE PORT

Applicant Arrow Intl., Inc.

K number K011761

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DYB 2001-10-23

MODIFICATION TO BRAIDED GUIDING INTRODUCER

Applicant Thomas Medical Products, Inc.

K number K013202

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DYB 2001-10-09

SEAL-AWAY CS INTRODUCER KIT, MODELS 407514, 407515

Applicant St Jude Medical

K number K013029

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DYB 2001-09-28

VYGON SPLIT CANNULA INTRODUCER

Applicant Vygon Corp.

K number K010913

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DYB 2001-09-25

ULTRAFLEX EV HEMOSTASIS INTRODUCER

Applicant St Jude Medical

K number K012922

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DYB 2001-09-05

MICROCRUISER PLUS INTRODUCER SET

Applicant Medical Device Technologies, Inc.

K number K011790

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DYB 2001-08-30

MODIFICATION TO: X-SEPT TRANSSEPTAL SHEALTH AND TRANSITION CATHETER (WITH DILATOR), MODELS PL-12-12-09, PL-12-12-10

Applicant Appriva Medical, Inc.

K number K012489

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DYB 2001-07-19

SPLITTABLE SHEATH INTRODUCER KIT

Applicant Thomas Medical Products, Inc.

K number K004025

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DYB 2001-07-09

GUIDEWIRE INTRODUCER SAFETY NEEDLE

Applicant Medamicus, Inc.

K number K011085

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DYB 2001-07-09

BRAIDED GUIDING INTRODUCER

Applicant Thomas Medical Products, Inc.

K number K004026

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DYB 2001-05-31

INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX

Applicant Maxxim Medical

K number K002847

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DYB 2001-04-26

EMBOL-X INTRODUCER, MODEL CF00200

Applicant Embol-X, Inc.

K number K002973

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DYB 2001-04-10

SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE

Applicant Thomas Medical Products, Inc.

K number K003731

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DYB 2001-03-21

TWO-LUMEN CENTRAL VENOUS ACCESS KIT WITH HEMOSTASIS VALVE/SIDE PORT

Applicant Arrow Intl., Inc.

K number K002507

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DYB 2001-02-16

X-SEPT TRANSSEPTAL SHEATH AND TRANSITION CATHETER, MODEL MV-03-09-90, MV-03-10-90, MV-03-11-90, MV-03-09-120, MV-03-10-1

Applicant Appriva Medical, Inc.

K number K002054

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DYB 2001-01-25

INTRODEUCE DOUBLE LUMEN INTRODUCER

Applicant Cook, Inc.

K number K001985

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DYB 2001-01-03

ULTIMUM EV HEMOSTASIS INTRODUCER (14F), ULTIMUM EV HEMOSTASIS INTRODUCER (16F), ULTIMUM EV HEMOSTASIS INTRODUCER (18F),

Applicant St Jude Medical

K number K003729

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DYB 2000-11-29

ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509

Applicant Daig Corp.

K number K000004

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DYB 2000-11-21

PINNACLE R/O II OR RADIFOCUS INTRODUCER II

Applicant Terumo Medical Corp.

K number K003424

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DYB 2000-10-30

ENDOVANCE DUALPASS TEAR-AWAY SHEATH INTRODUCER

Applicant Guidant Cardiac and Vascular Surgery

K number K002676

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DYB 2000-09-22

VASCULAR GRAFT TUNNELER-STANDARD CURVE, MID CURVE, FULL CURVE, SHORT STANDARD CURVE, VASCULAR GRAFT TUNNELER ACCESSORIES

Applicant Thoratec Laboratories Corp.

K number K001926

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DYB 2000-08-25

DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET

Applicant Datascope Corp.

K number K002365

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DYB 2000-07-03

6F & 7F INTRODUCING CATHETERS (MODIFICATION)

Applicant Cordis Corp.

K number K001135

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