Wire, Guide, Catheter

FDA product code DQX · 735 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.1330
Review panel: CV
Implant: No
Life sustaining: No
Third party review: Yes
GMP exempt: No
Clearance span: 1976-12-10 – 2026-09-18

DQX 2010-09-27

PERCU-PRO GUIDEWIRE

Applicant Cardiosolutions, Inc.

K number K094062

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DQX 2010-09-23

NEOWIRE PTA/PTCA GUIDEWIRE

Applicant Neometrics, Inc.

K number K101729

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DQX 2010-09-22

ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S

Applicant Asahi Intecc Co., Ltd.

K number K100578

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DQX 2010-09-03

CRUISER 18 GUIDEWIRE

Applicant Brivant, Ltd.

K number K102211

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DQX 2010-08-31

ARCHER SUPER STIFF GUIDEWIRES

Applicant Medtronic, Inc.

K number K101339

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DQX 2010-07-08

HI-TORQUE WINN GUIDE WIRE FAMILY

Applicant Abbott Vascular, Inc.

K number K101648

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DQX 2010-06-23

HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH

Applicant Abbott Vascular-Cardiac Therapies

K number K101116

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DQX 2010-06-17

HASKAL TORQUE DEVICE

Applicant Elcam Medical Acal

K number K100425

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DQX 2010-05-24

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL

Applicant Abbott Vascular, Inc.

K number K101011

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DQX 2010-04-30

PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J

Applicant Volcano Corporation

K number K100930

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DQX 2010-04-30

VSI TORQUE DEVICE

Applicant Vascular Solutions, Inc.

K number K100093

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DQX 2010-04-28

ROLL-X GUIDEWIRE

Applicant St Jude Medical

K number K100710

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DQX 2010-04-21

GTX 12 GIDEWIRE

Applicant Medtronic, Inc.

K number K100470

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DQX 2010-03-16

NEUROSCOUT STEERABLE GUIDEWIRE

Applicant Codman & Shurtleff, Inc.

K number K100351

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DQX 2010-02-26

TRAILRUNNER GUIDEWIRES

Applicant Lake Region Mfg., Inc.

K number K092965

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DQX 2010-02-24

TRAXCESS DOCKING WIRE

Applicant MicroVention, Inc.

K number K093647

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DQX 2010-02-16

3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON

Applicant Brivant, Ltd.

K number K093515

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DQX 2010-01-28

DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY

Applicant Shepherd Scientific, Inc.

K number K093822

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DQX 2010-01-26

MERIDIAN GUIDEWIRE

Applicant Ev3 Neurovascular

K number K093681

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DQX 2009-12-17

TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE

Applicant MicroVention, Inc.

K number K093397

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DQX 2009-12-04

GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15

Applicant Medtronic Vascular

K number K091582

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DQX 2009-10-27

MERIT LAUREATE HYDROPHILIC GUIDE WIRE

Applicant Merit Medical Systems, Inc.

K number K092303

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DQX 2009-09-25

HI-TORQUE PROGRESS GUIDE WIRE FAMILY

Applicant Abbott Vascular, Inc.

K number K091825

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DQX 2009-09-25

CONDUCTOR CORONARY GUIDEWIRE

Applicant Concert Medical, LLC

K number K090193

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DQX 2009-08-07

APPROACH HYDRO ST WIRE GUIDE, MODEL HMW

Applicant Cook, Inc.

K number K091385

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DQX 2009-07-07

STREAMER POLYMER GUIDEWIRE

Applicant Brivant, Ltd.

K number K083094

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DQX 2009-07-02

ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE

Applicant Boston Scientific Corp

K number K090554

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DQX 2009-03-25

THE MEDCOMP .010 VASCULAR GUIDEWIRES

Applicant Medcomp

K number K081775

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DQX 2009-03-11

HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05

Applicant Abbott Vascular

K number K083738

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DQX 2009-03-03

MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE

Applicant Micrus Endovascular Corporation

K number K090274

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DQX 2009-02-25

TAD AND TAD II TAPERED GUIDE WIRES

Applicant Abbott Vascular

K number K083732

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DQX 2009-02-23

.035 LOC GUIDE WIRE EXTENSION

Applicant Abbott Vascular

K number K083713

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DQX 2009-02-20

STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012

Applicant Bridgepoint Medical

K number K083727

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DQX 2009-02-06

HI-TORQUE VERSACORE GUIDE WIRE

Applicant Abbott Vascular

K number K083706

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DQX 2009-02-06

MEDTRONIC ANGIOGRAPHIC GUIDE WIRES

Applicant Medtronic Vascular

K number K082873

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DQX 2009-01-29

ASAHI SUOH PTCA GUIDE WIRE

Applicant Asahi Intecc Co., Ltd.

K number K083904

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DQX 2009-01-12

ASAHI GUIDE WIRE EXTENSION, MODEL AG149000

Applicant Asahi Intecc Co., Ltd.

K number K083145

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DQX 2008-12-17

BARD PTFE (TEFLON) COATED GUIDE WIRES

Applicant C.R. Bard Inc., Bard Electrophysiology Division

K number K082094

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DQX 2008-12-09

FREEWAY AND RAILRUNNER GUIDEWIRES

Applicant Lake Region Mfg., Inc.

K number K082922

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DQX 2008-12-04

VISION WIRE CORONARY GUIDEWIRE

Applicant Biotronik, Inc.

K number K082935

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DQX 2008-11-21

ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000

Applicant Asahi Intecc Co., Ltd.

K number K083146

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DQX 2008-10-08

BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001

Applicant Bridgepoint Medical

K number K081187

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DQX 2008-08-27

ROLL-X GUIDEWIRE

Applicant St Jude Medical

K number K082304

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DQX 2008-08-12

POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS

Applicant Stereotaxis, Inc.

K number K080637

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DQX 2008-08-11

FINDRWIRZ GUIDE WIRE SYSTEM

Applicant Sentreheart, Inc.

K number K080364

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DQX 2008-08-08

APPROACH CTO WIRE GUIDE

Applicant Cook Incorporated

K number K081337

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DQX 2008-08-08

KINETIX GUIDEWIRE, PLUS GUIDEWIRE

Applicant Boston Scientific Corp

K number K081021

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DQX 2008-06-20

CROSSER LP SYSTEM

Applicant Flowcardia, Inc.

K number K080765

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DQX 2008-04-17

TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE

Applicant MicroVention, Inc.

K number K080863

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DQX 2008-04-11

HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

Applicant Abbott Vascular, Inc.

K number K072460

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DQX 2008-03-20

RUNTHROUGH NS EXTENSION WIRE

Applicant Terumo Medical Corp.

K number K080563

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DQX 2008-02-26

MANDREL GUIDEWIRES OR M-WIRES

Applicant Lake Region Mfg., Inc.

K number K080144

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DQX 2008-02-08

SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM, SAFE-CROSS(R) RADIO FREQUENCY TOTAL OCCLUSION CROSSING

Applicant Kensey Nash Corporation

K number K073162

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DQX 2008-01-28

PEGASUS STEERABLE (PTCA) GUIDEWIRE

Applicant Lake Region Mfg., Inc.

K number K073655

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DQX 2008-01-09

CPS COURIER GUIDEWIRE

Applicant Brivant, Ltd.

K number K073082

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DQX 2008-01-09

ASAHI PTCA GUIDE WIRE

Applicant Asahi Intecc Co., Ltd.

K number K070945

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DQX 2007-12-14

MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE

Applicant Merit Medical Systems, Inc.

K number K072552

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DQX 2007-10-23

ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J

Applicant Asahi Intecc Co., Ltd.

K number K072705

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DQX 2007-10-12

CITOP10 GUIDEWIRE, 0.014(1.4MM TIP), CITOP6 GUIDEWIRE, 0.014(1.0MM TIP), CITOP SUPPORT ACCESSORY, 0.023(126CM)

Applicant Ovalum , Ltd.

K number K070212

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DQX 2007-09-26

ASAHI PTCA GUIDE WIRE, X-TREME

Applicant Asahi Intecc Co., Ltd.

K number K072431

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DQX 2007-08-24

CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)

Applicant Stereotaxis, Inc.

K number K071029

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DQX 2007-07-13

ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371

Applicant Asahi Intecc Co., Ltd.

K number K071721

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DQX 2007-05-24

OSTIAL PRO STENT POSITIONING SYSTEM

Applicant Ostial Solutions, LLC

K number K062192

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DQX 2007-04-27

COOK MICROWIRE WIRE GUIDE

Applicant Cook, Inc.

K number K070410

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DQX 2007-04-27

RUNTHROUGH NS

Applicant Terumo Medical Corp.

K number K063695

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DQX 2007-03-15

ATTAIN HYBRID GUIDE WIRES, MODEL GWR419378, GWR419388, GWR419478, GWR419488

Applicant Medtronic Inc. Cardiac Rhythm Management

K number K063210

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DQX 2007-02-15

VASCUPUNCTURE PICC GUIDEWIRE

Applicant Neometrics, Inc.

K number K070150

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DQX 2007-01-26

ASAHI PTCA GUIDE WIRE, FIELDER FC

Applicant Asahi Intecc Co., Ltd.

K number K063819

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DQX 2007-01-19

RADIFOCUS GLIDEWIRE ADVANTAGE

Applicant Terumo Medical Corp.

K number K063372

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DQX 2007-01-19

LUNDERQUIST WIRE GUIDE; DC WIRE GUIDE

Applicant William Cook Europe Aps

K number K061670

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DQX 2006-11-09

ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J

Applicant Asahi Intecc Co., Ltd.

K number K062186

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DQX 2006-10-05

TREASURE

Applicant Asahi Intecc Co., Ltd.

K number K061984

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DQX 2006-06-22

HI-TORQUE WHISPER VIEW GUIDE WIRE

Applicant Guidant Corp.

K number K061453

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DQX 2006-06-07

BRIVANT GUIDEWIRE

Applicant Brivant Limited

K number K060551

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DQX 2006-06-02

SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX

Applicant Biosphere Medical, Inc.

K number K061171

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DQX 2006-05-30

HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE

Applicant Guidant Corporation

K number K060449

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DQX 2006-04-28

MICRUS GUIDE WIRE, WATUSI 0.014

Applicant Micrus Endovascular Corporation

K number K053265

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DQX 2006-04-27

AMPLATZER NOODLEWIRE GUIDEWIRE

Applicant Aga Medical Corp.

K number K053187

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DQX 2006-03-24

TITAN GUIDEWIRE

Applicant Lake Region Mfg., Inc.

K number K060454

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DQX 2006-03-13

PVS 2000 SYNCHRO2 GUIDEWIRE

Applicant Boston Scientific - Precision Vascular

K number K053268

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DQX 2006-03-08

TECHDEVICE GUIDEWIRE

Applicant Techdevice Corporation

K number K053251

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DQX 2006-02-17

TITAN STEERABLE (PTCA) GUIDEWIRE

Applicant Lake Region Mfg., Inc.

K number K052347

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DQX 2005-11-30

ASAHI PTCA GUIDE WIRE

Applicant Asahi Intecc Co., Ltd.

K number K052339

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DQX 2005-10-27

MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX

Applicant Boston Scientific Corp

K number K052783

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DQX 2005-08-25

ASAHI PTCA GUIDE WIRE FIELDER

Applicant Asahi Intecc Co., Ltd.

K number K052022

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DQX 2005-07-15

VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO

Applicant Flowcardia, Inc.

K number K051062

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DQX 2005-06-23

CARDIODRIVE CATHETER ADVANCEMENT SYSTEM

Applicant Stereotaxis, Inc.

K number K051374

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DQX 2005-06-13

PV 1900 SYNCHRO 0.016 GUIDEWIRE

Applicant Boston Scientific - Precision Vascular

K number K050964

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DQX 2005-06-07

SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]

Applicant Intra Luminal Therapeutics, Inc.

K number K050915

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DQX 2005-05-26

CANALIZER HYDROPHILIC GUIDE WIRE

Applicant Medical Device Technologies, Inc.

K number K050873

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DQX 2005-05-05

SKIPPER AND SKIPPER RACE GUIDEWIRE

Applicant Invatec Innovative Technologies, S.R.L.

K number K050756

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DQX 2005-03-02

GALEO FOCUS GUIDE WIRE

Applicant Biotronik, Inc.

K number K042373

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DQX 2005-03-01

MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE

Applicant Neometrics, Inc.

K number K043398

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DQX 2005-02-28

MODIFICATION TO ENDOVASCULAR GUIDE WIRE

Applicant Stereotaxis, Inc.

K number K043457

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DQX 2005-02-08

STEREOTAXIS ENDOVASCULAR GUIDE WIRE

Applicant Stereotaxis, Inc.

K number K042854

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DQX 2005-01-12

ASAHI PTCA GUIDE WIRE, J SHAPE SERIES

Applicant Asahi Intecc Co., Ltd.

K number K043422

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DQX 2004-12-17

TORAYGUIDE GUIDEWIRE

Applicant Toray Industries (America), Inc.

K number K042370

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DQX 2004-12-17

CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE

Applicant Cordis Corp.

K number K040592

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DQX 2004-11-24

COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE

Applicant Volcano Therapeutics, Inc.

K number K042996

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DQX 2004-11-24

GUIDEWIRES

Applicant Rocket Medical Plc

K number K042264

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