Product code DQX

Current FDA Classification

Device name
Wire, Guide, Catheter
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.1330
Review panel
CV
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
Eligible

Related 510(k) Records

510(k)DeviceApplicantDecision date
K260544FMD 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 40FMD Co., Ltd.2026-03-20
K253746Enroute 0.014'' Transcarotid GuidewireLake Region Medical2026-03-19
K253262EmeryGlide™ (EG18008901)Nano4imaging GmbH2026-03-06
K253847Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)Merit Medical Ireland, Ltd.2026-01-31
K251385InQwire 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)Merit Medical Ireland, Ltd.2026-01-21
K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc.2026-01-09
K251596Lunderquist Extra Stiff Wire GuideWilliam Cook Europe Aps2025-11-09
K250203SureAx-Guide™Sureax Medical, LLC2025-10-17
K250031Amplatzer GuidewireABBOTT MEDICAL2025-10-03
K251181Splashwire 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)Merit Medical Ireland, Ltd.2025-08-29
K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireABBOTT MEDICAL2025-07-25
K250075Medtronic Stedi Extra Support GuidewireMedtronic, Inc.2025-06-13
K243733SION blue PLUSAsahi Intecc Co., Ltd.2025-04-02
K241962CrossloopAsahi Intecc Co., Ltd.2025-03-27
K242597CROSSLEAD 0.018inchAsahi Intecc Co., Ltd.2025-03-05
K241702CROSSLEAD 0.014inchAsahi Intecc Co., Ltd.2025-02-06
K241521Prelude Small O.D. Introducer Guide WireMerit Medical Systems, Inc.2024-12-10
K242824PTFE GuidewireLake Region Medical2024-12-06
K240818R2P Radifocus Glidewire AdvantageTerumo Corporation2024-11-26
K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireABBOTT MEDICAL2024-11-06
K241784Arrow® Nitinol WireTeleflex Medical2024-09-18
K240859Glidewire GT-RTerumo Corporation2024-08-21
K241510CROSSLEAD TrackerAsahi Intecc Co., Ltd.2024-08-14
K240387MINAMO blue; MINAMO violaAsahi Intecc Co., Ltd.2024-06-21
K240460FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)FMD Co., Ltd.2024-06-13
K240864PacePro WireOpsens, Inc.2024-05-24
K232662BNLE Hydrophilic Jacketed Peripheral GuidewireBiomerics Nle2024-05-14
K230418Mighty Wire Guide WireMerit Medical Systems, Inc.2023-10-28
K232570Steerant™ Super Stiff GuidewireMedtronic Vascular2023-10-24
K232574VASSALLO GT Crossing14Filmec Co. , Ltd.2023-10-11

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