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 2026-09-18

Hyperdrive 35 Guidewire

Applicant Rapid-Medical , Ltd.

K number K253146

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DQX 2026-09-03

CROSSLEAD Standard 035 and CROSSLEAD Stiff 035

Applicant Filmecc Co., Ltd.

K number K261281

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DQX 2026-07-14

Accoat Guide Wire

Applicant Sp Medical A/S

K number K253667

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DQX 2026-07-13

Merit MAK Nitinol/Gold-Tungsten Guide Wire

Applicant Merit Medical Ireland , Ltd.

K number K261640

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DQX 2026-05-22

InQwire Amplatz Guide Wire

Applicant Merit Medical Ireland, Ltd.

K number K254137

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DQX 2026-03-20

FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40

Applicant FMD Co., Ltd.

K number K260544

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DQX 2026-03-19

Enroute 0.014'' Transcarotid Guidewire

Applicant Lake Region Medical

K number K253746

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DQX 2026-03-06

EmeryGlide™ (EG18008901)

Applicant Nano4imaging GmbH

K number K253262

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DQX 2026-01-31

Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)

Applicant Merit Medical Ireland, Ltd.

K number K253847

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DQX 2026-01-21

InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)

Applicant Merit Medical Ireland, Ltd.

K number K251385

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DQX 2026-01-09

Solo Pace Fusion System (SOLOFUSE1)

Applicant Solo Pace, Inc.

K number K252674

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DQX 2025-11-09

Lunderquist Extra Stiff Wire Guide

Applicant William Cook Europe Aps

K number K251596

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DQX 2025-10-17

SureAx-Guide™

Applicant Sureax Medical, LLC

K number K250203

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DQX 2025-10-03

Amplatzer Guidewire

Applicant ABBOTT MEDICAL

K number K250031

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DQX 2025-08-29

Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT)

Applicant Merit Medical Ireland, Ltd.

K number K251181

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DQX 2025-07-25

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire

Applicant ABBOTT MEDICAL

K number K250552

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DQX 2025-06-13

Medtronic Stedi Extra Support Guidewire

Applicant Medtronic, Inc.

K number K250075

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DQX 2025-04-02

SION blue PLUS

Applicant Asahi Intecc Co., Ltd.

K number K243733

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DQX 2025-03-27

Crossloop

Applicant Asahi Intecc Co., Ltd.

K number K241962

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DQX 2025-03-05

CROSSLEAD 0.018inch

Applicant Asahi Intecc Co., Ltd.

K number K242597

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DQX 2025-02-06

CROSSLEAD 0.014inch

Applicant Asahi Intecc Co., Ltd.

K number K241702

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DQX 2024-12-10

Prelude Small O.D. Introducer Guide Wire

Applicant Merit Medical Systems, Inc.

K number K241521

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DQX 2024-12-06

PTFE Guidewire

Applicant Lake Region Medical

K number K242824

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DQX 2024-11-26

R2P Radifocus Glidewire Advantage

Applicant Terumo Corporation

K number K240818

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DQX 2024-11-06

Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire

Applicant ABBOTT MEDICAL

K number K240997

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DQX 2024-09-18

Arrow® Nitinol Wire

Applicant Teleflex Medical

K number K241784

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DQX 2024-08-21

Glidewire GT-R

Applicant Terumo Corporation

K number K240859

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DQX 2024-08-14

CROSSLEAD Tracker

Applicant Asahi Intecc Co., Ltd.

K number K241510

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DQX 2024-06-21

MINAMO blue; MINAMO viola

Applicant Asahi Intecc Co., Ltd.

K number K240387

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DQX 2024-06-13

FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)

Applicant FMD Co., Ltd.

K number K240460

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DQX 2024-05-24

PacePro Wire

Applicant Opsens, Inc.

K number K240864

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DQX 2024-05-14

BNLE Hydrophilic Jacketed Peripheral Guidewire

Applicant Biomerics Nle

K number K232662

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DQX 2023-10-28

Mighty Wire Guide Wire

Applicant Merit Medical Systems, Inc.

K number K230418

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DQX 2023-10-24

Steerant™ Super Stiff Guidewire

Applicant Medtronic Vascular

K number K232570

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DQX 2023-10-11

VASSALLO GT 018 G12; VASSALLO GT 018 G30

Applicant Filmec Co. , Ltd.

K number K232578

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DQX 2023-10-11

VASSALLO GT Crossing14

Applicant Filmec Co. , Ltd.

K number K232574

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DQX 2023-07-20

CROSSLEAD Penetration Peripheral Guide Wire

Applicant Asahi Intecc Co., Ltd.

K number K230377

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DQX 2023-07-14

TalWire

Applicant Embrace Medical , Ltd.

K number K223791

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DQX 2023-05-05

Wattson temporary pacing guidewire (2250)

Applicant Vascular Solutions, LLC

K number K230637

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DQX 2023-04-28

BNLE Access Guidewire

Applicant Biomerics Nle

K number K221390

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DQX 2023-03-09

Vassallo GT 018 Hybrid

Applicant Filmecc Co., Ltd.

K number K223432

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DQX 2023-03-01

ProTrack Pigtail Wire

Applicant Baylis Medical Company, Inc.

K number K213898

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DQX 2022-12-19

Mechanical Guidewire

Applicant Baylis Medical Company, Inc.

K number K221351

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DQX 2022-10-26

VASSALLO GT EXT

Applicant Filmecc Co., Ltd.

K number K222631

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DQX 2022-10-07

Pre-Formed Blue

Applicant Lake Region Medical

K number K221575

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DQX 2022-09-21

EpiFaith CV

Applicant Flat Medical Co., Ltd.

K number K212615

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DQX 2022-09-14

SavvyWire

Applicant Opsens, Inc.

K number K213854

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DQX 2022-09-06

ASAHI Gladius Mongo18 PV ES

Applicant Asahi Intecc Co., Ltd.

K number K213868

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DQX 2022-08-19

Stent Positioning Assistance System (SPAS)

Applicant Seven Sons , Ltd.

K number K221917

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DQX 2022-07-01

CROSSLEAD Peripheral Guide Wire

Applicant Asahi Intecc Co., Ltd.

K number K213315

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DQX 2022-06-30

VASSALLO GT 018 Floppy

Applicant Filmecc Co., Ltd.

K number K213949

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DQX 2022-05-27

FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT

Applicant FMD Co., Ltd.

K number K212268

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DQX 2022-05-17

Medline Integrated Arterial Catheter

Applicant Centurion Medical Products

K number K210548

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DQX 2022-04-19

Spartan Center Wire

Applicant Spartan Micro, Inc.

K number K220075

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DQX 2022-03-18

Cardio Flow Peripheral Guide Wire

Applicant Cardio Flow Inc.,

K number K213834

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DQX 2022-02-17

Lunderquist Extra Stiff Wire Guide

Applicant William Cook Europe Aps

K number K220137

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DQX 2022-02-09

R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire

Applicant Vascular Solutions, LLC

K number K212167

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DQX 2021-12-08

ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20

Applicant Asahi Intecc Co., Ltd.

K number K211898

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DQX 2021-11-22

Pre-Formed Extra Support Guidewire

Applicant Lake Region Medical

K number K211741

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DQX 2021-05-04

VASSALLO GT Hybrid

Applicant Filmecc Co., Ltd.

K number K203529

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DQX 2021-04-21

VASSALLO GT

Applicant Filmecc Co., Ltd.

K number K203533

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DQX 2021-04-15

Verrata PLUS Pressure Guide Wire

Applicant Volcano Corporation

K number K210235

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DQX 2021-02-18

LiPPS Analyzer, LiPPS Wire Pressure Guide Wire

Applicant Beijing Bywave Sensing Medical Technology Co., Ltd.

K number K201720

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DQX 2020-10-14

Merit Hydrophilic Guide Wire

Applicant Merit Medical Systems, Inc.

K number K201595

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DQX 2020-09-28

OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip

Applicant Volcano Corporation

K number K202543

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DQX 2020-08-26

Hydrophilic Coating Guide Wire

Applicant Suzhou Hengrui Disheng Medical Co., Ltd.

K number K193653

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DQX 2020-07-30

HI-TORQUE PROCEED Guide Wire Family

Applicant Abbott Vascular

K number K201834

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DQX 2020-07-29

Zoom 14 Guidewire

Applicant Scientia Vascular, LLC

K number K201760

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DQX 2020-07-21

Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K number K201690

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DQX 2020-05-07

LiteSaber Wire Torque Assist Device

Applicant Vesatek, LLC

K number K200120

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DQX 2020-04-08

HI-TORQUE Steelcore Bare Guide Wire

Applicant Abbott Vascular

K number K200144

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DQX 2020-04-08

Go2Wire Guide Wire

Applicant Merit Medical System, Inc.

K number K193571

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DQX 2020-03-26

OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip

Applicant Volcano Corporation

K number K192886

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DQX 2020-01-18

Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire

Applicant Micro Therapeutics, Inc. d/b/a ev3 Neurovascular

K number K193548

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DQX 2020-01-15

Wattson Temporary Pacing Guidewire

Applicant Vascular Solutions

K number K192454

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DQX 2020-01-02

ASAHI PTCA Guide Wire ASAHI Gaia Next

Applicant Asahi Intecc Co., Ltd.

K number K192599

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DQX 2020-01-02

OptoWire III

Applicant Opsens, Inc.

K number K191907

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DQX 2019-12-13

CrossTorq 14 Guidewire

Applicant Scientia Cardio Access, LLC

K number K193194

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DQX 2019-12-11

HI-TORQUE InfilTrac Guide Wire Family

Applicant Abbott Vascular

K number K193126

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DQX 2019-11-26

Heraeus Peripheral Guidewire

Applicant Heraeus Medical Components, LLC

K number K191502

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DQX 2019-11-21

Asahi PTCA Guide Wire Asahi SION Series

Applicant Asahi Intecc Co., Ltd.

K number K191464

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DQX 2019-10-30

Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard Profile ; Aristotle 24 Guidewire, 200cm, Support Profile

Applicant Scientia Vascular, LLC

K number K192783

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DQX 2019-10-09

pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire

Applicant Phenox Limited

K number K191687

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DQX 2019-08-01

MINAMO

Applicant Asahi Intecc Co., Ltd.

K number K190176

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DQX 2019-07-22

Roadrunner PC Wire Guide, Olcott Torque Device

Applicant Cook Incorporated

K number K182985

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DQX 2019-07-01

ASAHI Silverway

Applicant Asahi Intecc Co., Ltd.

K number K183062

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DQX 2019-04-18

Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J

Applicant Brivant Limited (Lake Region Medical)

K number K182457

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DQX 2019-03-11

Inno-Pathwire

Applicant Suzhou Innomed Medical Device Co., Ltd.

K number K182553

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DQX 2019-02-15

Lunderquist® Fixed Core Wire Guide

Applicant Cook Incorporated

K number K181353

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DQX 2019-01-11

Roadrunner Extra Support Wire Guide

Applicant Cook Incorporated

K number K183467

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DQX 2018-12-20

Reuter Tip Deflecting Wire Guide

Applicant Cook Incorporated

K number K180830

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DQX 2018-09-26

Magic Torque DLVR Guidewire

Applicant Boston Scientific Corporation

K number K182315

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DQX 2018-07-20

Bandit guidewire

Applicant Vascular Solutions, Inc.

K number K181647

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DQX 2018-07-18

ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES

Applicant Asahi Intecc Co., Ltd.

K number K180784

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DQX 2018-07-05

ASAHI PTCA Guide Wire ASAHI SION black

Applicant Asahi Intecc Co., Ltd.

K number K173277

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DQX 2018-06-18

Savion DLVR Guidewire, Savion FLX Guidewire

Applicant Boston Scientific, Inc.

K number K180726

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DQX 2018-06-14

Double Flexible Tipped Wire Guides

Applicant Cook Incorporated

K number K181351

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DQX 2018-05-03

Medtronic Confida Brecker Guidewire

Applicant Medtronic Core Valve, LLC

K number K181001

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DQX 2018-04-12

JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire

Applicant Boston Scientific

K number K180795

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DQX 2018-04-11

Inno-Hydrowire

Applicant Suzhou Innomed Medical Device Co., Ltd.

K number K172187

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