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 1999-02-03

PRESSUREWIRE SENSOR, MODEL #12001

Applicant Radi Medical Systems AB

K number K983506

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DQX 1999-02-01

GUIDEWIRE

Applicant Galt Medical Corp.

K number K982559

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DQX 1999-01-08

GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018

Applicant Biotronik, Inc.

K number K982272

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DQX 1998-12-11

SILVERSTREAK HYDROPHILIC GUIDEWIRE

Applicant Micro Therapeutics, Inc.

K number K982543

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DQX 1998-11-12

STRATEGY CORONARY WIRE GUIDE

Applicant Cook, Inc.

K number K983771

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DQX 1998-11-12

SCIMED INFORMER PRESSURE WIRE SYSTEM

Applicant Scimed Life Systems, Inc.

K number K974241

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DQX 1998-11-10

ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE

Applicant Guidant Corp.

K number K983033

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DQX 1998-11-10

HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282

Applicant Guidant Corp.

K number K982876

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DQX 1998-10-27

PIOLAX HYDROPHILIC GUIDEWIRE

Applicant Piolax Medical Devices, Inc.

K number K980977

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DQX 1998-10-21

DOCKING-EXTENSION WIRE

Applicant Schneider (Europe) GmbH

K number K982592

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DQX 1998-10-14

BARD HYDROPHILLIC COATED GUIDE WIRE

Applicant C.R. Bard, Inc.

K number K974713

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DQX 1998-09-11

ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

Applicant Guidant Corp.

K number K982083

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DQX 1998-07-22

CORE AND COIL ASSEMBLY GUIDEWIRE

Applicant Lake Region Mfg., Inc.

K number K971322

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DQX 1998-07-15

ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1

Applicant Guidant Corp.

K number K981381

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DQX 1998-07-10

LAKE REGION MANUFACTURING GUIDEWIRES

Applicant Lake Region Mfg., Inc.

K number K981326

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DQX 1998-05-11

CORDIS VANGUARD STEERABLE GUIDEWIRES

Applicant Cordis Corp.

K number K974560

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DQX 1998-04-29

SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES

Applicant Scimed Life Systems, Inc.

K number K980360

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DQX 1998-04-24

ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

Applicant Guidant Corp.

K number K980294

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DQX 1998-04-24

PRESSURE WIRE SENSOR .014, PRESSURE WIRE INTERFACE 10, PRESSURE WIRE MONITOR CABLE

Applicant Radi Medical Systems AB

K number K972793

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DQX 1998-03-20

ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE

Applicant Guidant Corp.

K number K980119

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DQX 1998-03-13

HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILIC

Applicant Guidant Corp.

K number K974773

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DQX 1998-01-12

LUGE GUIDE WIRE

Applicant Scimed Life Systems, Inc.

K number K973945

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DQX 1998-01-05

CORDIS HYDRONOL STEERABLE GUIDEWIRE

Applicant Cordis Corp.

K number K973845

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DQX 1997-12-19

TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL

Applicant Merit Medical Systems, Inc.

K number K973708

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DQX 1997-12-19

RADIAL AND FEMORAL ARTERY CATHETER

Applicant B.Braun Medical, Inc.

K number K971086

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DQX 1997-12-12

HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG

Applicant Guidant Corp.

K number K973494

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DQX 1997-12-11

IVT 0.014 PTFE-COATED TRACKWIRE

Applicant Boston Scientific /International Technologies

K number K971688

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DQX 1997-11-17

HUNTER 0.014 INCH SUPER SOFT / HUNTER O.014 INCH SOFT GUIDE WIRES W/THROMBORESISTANT PC COATING

Applicant Biocompatibles Cardiovascular, Inc.

K number K970938

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DQX 1997-11-03

MEDTRONIC MUSTANG SUPER FLOPPY GUIDE WIRE/FLOPPY GUIDE WIRE/INTERMEDIATE GUIDE WIRE/STANDARD GUIDE WIRE/EXTRA SUPPORT

Applicant Medtronics Interventional Vascular

K number K972944

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DQX 1997-11-03

THEROX INFUSION GUIDEWIRES

Applicant Therox, Inc.

K number K971719

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DQX 1997-10-14

CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES

Applicant Cardio Metrics, Inc.

K number K972762

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DQX 1997-10-09

RAULERSON ONE-STEP GUIDEWIRE INSERTION BULB NEEDLE

Applicant Medcomp

K number K971281

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DQX 1997-09-17

ACS HI-TORQUE RULER GUIDE WIRE

Applicant Guidant Corp.

K number K972290

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DQX 1997-08-25

ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATING

Applicant Guidant Corp.

K number K972142

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DQX 1997-08-18

CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM

Applicant Cardio Metrics, Inc.

K number K965140

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DQX 1997-07-14

GUGLIELMI DETACHABLE COIL (GDC), FIBERED PLATINUM COIL, .035 TYPE, BERENSTEIN LIQUID COIL, FIBERED PLATINUM COILS, ACCE

Applicant Target Therapeutics

K number K971395

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DQX 1997-07-09

ASC BALANCE MIDDLEWEIGHT GUIDE WIRE

Applicant Guidant Corp.

K number K971815

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DQX 1997-07-01

TRANSEND EX PLATINUM GUIDEWIRE

Applicant Boston Scientific Corp

K number K971254

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DQX 1997-06-10

CLYDE CORONARY GUIDEWIRE

Applicant Schneider (Europe) GmbH

K number K970528

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DQX 1997-06-06

PTCA GUIDEWIRE

Applicant Lake Region Mfg., Inc.

K number K970376

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DQX 1997-05-21

CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID

Applicant Scimed Life Systems, Inc.

K number K964551

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DQX 1997-05-20

LOCKING STYLET 2

Applicant Cook Pacemaker Corp.

K number K970690

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DQX 1997-05-09

HANNIBAL GUIDEWIRE

Applicant Schneider (Europe) GmbH

K number K970494

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DQX 1997-03-28

SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES

Applicant Scimed Life Systems, Inc.

K number K970244

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DQX 1997-03-04

CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE

Applicant Scimed Life Systems, Inc.

K number K965023

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DQX 1997-02-21

CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS)

Applicant Cordis Corp.

K number K962765

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DQX 1997-01-28

TRANSEND GUIDEWIRE

Applicant Boston Scientific Corp

K number K964611

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DQX 1997-01-28

TORQUE DEVICE

Applicant B.Braun Medical, Inc.

K number K964352

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DQX 1997-01-22

ACS HI-TORQUE IRON MAN GUIDE WIRE

Applicant Advanced Cardiovascular Systems, Inc.

K number K963702

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DQX 1996-12-17

SCIMED CHOICE PT VISION PTCA GUIDE WIRE

Applicant Scimed Life Systems, Inc.

K number K962572

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DQX 1996-12-17

HYDRO-SELECT GUIDEWIRE

Applicant Microvena Corp.

K number K954642

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DQX 1996-12-03

TFX MEDICAL GUIDEWIRE

Applicant Tfx Medical Group

K number K963320

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DQX 1996-11-20

MEDTRONIC MUSTANG STEERABLE GUIDE WIRE (M-45FR, M45FX)

Applicant Medtronics Interventional Vascular

K number K961917

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DQX 1996-11-13

CORDIS ST STEERABLE GUIDEWIRE

Applicant Cordis Corp.

K number K963214

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DQX 1996-11-07

CINCH QR SGW EXTENSION

Applicant Cordis Corp.

K number K963171

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DQX 1996-10-25

CORDIS STABILIZER PLUS XS

Applicant Cordis Corp.

K number K962932

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DQX 1996-10-01

B. BRAUN GUIDEWIRES

Applicant B.Braun Medical, Inc.

K number K961107

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DQX 1996-09-10

0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING

Applicant Biocompatibles Cardiovascular, Inc.

K number K962266

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DQX 1996-07-31

ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404

Applicant Cardio Metrics, Inc.

K number K961777

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DQX 1996-07-09

RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL

Applicant Terumo Medical Corp.

K number K961445

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DQX 1996-06-27

USCI COMMANDER SERIES GUIDE WIRES

Applicant C.R. Bard, Inc.

K number K961271

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DQX 1996-06-26

0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP

Applicant Biocompatibles , Ltd.

K number K961232

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DQX 1996-05-23

CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS

Applicant Medtronic Cardiac Surgery, Medtronic, Inc.

K number K960755

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DQX 1996-05-21

LRM

Applicant Lake Region Mfg., Inc.

K number K960718

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DQX 1996-05-16

CRICKET

Applicant Microvena Corp.

K number K955304

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DQX 1996-05-15

SCIMED CHOICE/PTCA GUIDE WIRE/PLUS PTCA GUIDE WIRE/EXCHANGE PTCA GUIDE WIRE

Applicant Scimed Life Systems, Inc.

K number K961015

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DQX 1996-04-29

SCIMED CHOICE PT EXCHANGE EXTRA SUPPORT PTCA AND LONG TAPER PTCA GUIDE WIRE

Applicant Scimed Life Systems, Inc.

K number K960657

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DQX 1996-04-29

SCIMED SCEPTOR & SCEPTOR EXCHANGE PTCA GUIDE WIRES

Applicant Scimed Life Systems, Inc.

K number K960563

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DQX 1996-04-29

IVT 0.014 TRACK OR IVT 0.014 ACCUTRACK

Applicant Boston Scientific /International Technologies

K number K954622

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DQX 1996-04-29

RAILWIRE

Applicant Boston Scientific /International Technologies

K number K954552

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DQX 1996-04-09

0.014 INTERMEDIATE GUIDE WIRE W/PHOSPHORYLCHOLINE POLYMER COATING

Applicant Biocompatibles , Ltd.

K number K955135

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DQX 1996-04-05

ACS ANCHOR EXCHANGE DEVICE

Applicant Advanced Cardiovascular Systems, Inc.

K number K955175

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DQX 1996-03-11

ESSENCE GUIDEWIRE

Applicant Cordis Neurovascular, Inc.

K number K955637

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DQX 1996-02-28

CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404

Applicant Cardio Metrics, Inc.

K number K955551

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DQX 1996-02-02

RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD

Applicant Terumo Medical Corp.

K number K955801

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DQX 1995-12-22

GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS

Applicant Datascope Corp.

K number K943896

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DQX 1995-12-13

THE NINER NITINOL GUIDEWIRE

Applicant Microvena Corp.

K number K952860

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DQX 1995-11-17

ENTERPRISE

Applicant Camp Intl., Inc.

K number K935998

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DQX 1995-11-07

CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION)

Applicant Cardio Metrics, Inc.

K number K954913

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DQX 1995-11-07

CORDIS WIZDOM STEERABLE GUIDEWIRE

Applicant Cordis Corp.

K number K953760

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DQX 1995-10-18

RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL

Applicant Terumo Medical Corp.

K number K953533

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DQX 1995-09-21

PRECEDER GUIDEWIRE

Applicant Boston Scientific Corp

K number K953023

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DQX 1995-08-29

CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE

Applicant Cardio Metrics, Inc.

K number K952562

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DQX 1995-08-18

FINESSE GUIDEWIRE CORONARY

Applicant Flexmedics

K number K952430

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DQX 1995-07-20

CORDIS STEERABLE GUIDEWIRE

Applicant Cordis Corp.

K number K952067

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DQX 1995-07-10

URESIL(R) GUIDEWIRE

Applicant Uresil Corp.

K number K945934

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DQX 1995-06-27

FLEXFINDER GUIDEWIRE

Applicant Flexmedics

K number K943390

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DQX 1995-06-22

BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES

Applicant Baxter Healthcare Corp

K number K951307

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DQX 1995-06-22

SCIMED CHOICE PT PLUS(RM) PTCA GUIDE WIRE

Applicant Scimed Life Systems, Inc.

K number K950216

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DQX 1995-06-08

C-THRU CORONARY GUIDE WIRE

Applicant Schneider (Europe) GmbH

K number K951109

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DQX 1995-06-05

PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING

Applicant Boston Scientific Corp

K number K945379

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DQX 1995-06-02

NAVIGUIDE HYDROPHILIC GUIDE WIRE

Applicant Meadox Medicals, Div. Boston Scientific Corp.

K number K943358

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DQX 1995-05-25

SCIMED CHOICE PT PTCA GUIDE WIRE

Applicant Scimed Life Systems, Inc.

K number K950835

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DQX 1995-05-15

ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITS

Applicant Advanced Cardiovascular Systems, Inc.

K number K950752

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DQX 1995-04-28

SCIMED SCEPTOR EXCHANGE GUIDE WIRE

Applicant Scimed Life Systems, Inc.

K number K950535

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DQX 1995-04-28

SCIMED SCEPTOR PTCA GUIDE WIRE

Applicant Scimed Life Systems, Inc.

K number K950534

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DQX 1995-04-28

PRECEDER GUIDEWIRE

Applicant Boston Scientific Corp

K number K950352

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DQX 1995-04-14

CORDIS STEERABLE GUIDEWIRES

Applicant Cordis Corp.

K number K950316

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DQX 1995-04-14

SCIMED(R) CHOICE(TM) PT EXCHANGE PTCA GUIDE WIRE

Applicant Scimed Life Systems, Inc.

K number K950266

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DQX 1995-04-12

DASHER-14

Applicant Target Therapeutics

K number K950069

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