FDA 510(k)

Merit MAK Nitinol/Gold-Tungsten Guide Wire

N.º K: K261640 · 2026-07-13

Fecha de decisión2026-07-13

Código de productoDQX

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Merit MAK Nitinol/Gold-Tungsten Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Ireland , Ltd.. It received FDA 510(k) clearance on 2026-07-13 under 510(k) number K261640. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Merit MAK Nitinol/Gold-Tungsten Guide Wire?

Merit MAK Nitinol/Gold-Tungsten Guide Wire is a medical device that received FDA 510(k) clearance on 2026-07-13. The listed applicant is Merit Medical Ireland , Ltd.. The 510(k) number is K261640.

When did Merit MAK Nitinol/Gold-Tungsten Guide Wire receive FDA 510(k) clearance?

Merit MAK Nitinol/Gold-Tungsten Guide Wire received FDA 510(k) clearance on 2026-07-13, under 510(k) number K261640.

Who is the listed applicant for Merit MAK Nitinol/Gold-Tungsten Guide Wire?

The FDA 510(k) record lists Merit Medical Ireland , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Merit MAK Nitinol/Gold-Tungsten Guide Wire?

The FDA product code for Merit MAK Nitinol/Gold-Tungsten Guide Wire is DQX.

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Otros registros que enlistan a Merit Medical Ireland , Ltd. como solicitante

K254137InQwire Amplatz Guide Wire K253847Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)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)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)

Dispositivos relacionados (Código: DQX)

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/S K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.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.K253746Enroute 0.014'' Transcarotid GuidewireLake Region Medical

Fuente oficial

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