FDA 510(k)

InQwire Amplatz Guide Wire

K-Number: K254137 · 2026-05-22

Decision Date2026-05-22

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

InQwire Amplatz 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 2026-05-22 under 510(k) number K254137. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the InQwire Amplatz Guide Wire?

InQwire Amplatz Guide Wire is a medical device that received FDA 510(k) clearance on 2026-05-22. The listed applicant is Merit Medical Ireland, Ltd.. The 510(k) number is K254137.

When did InQwire Amplatz Guide Wire receive FDA 510(k) clearance?

InQwire Amplatz Guide Wire received FDA 510(k) clearance on 2026-05-22, under 510(k) number K254137.

Who is the listed applicant for InQwire Amplatz 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 InQwire Amplatz Guide Wire?

The FDA product code for InQwire Amplatz Guide Wire is DQX.

Other records listing Merit Medical Ireland, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261640Merit MAK Nitinol/Gold-Tungsten 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)

Related Devices (Code: DQX)

K253667Accoat Guide WireSp Medical A/S K261640Merit MAK Nitinol/Gold-Tungsten 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 K253262EmeryGlide™ (EG18008901)Nano4imaging GmbH K253847Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)Merit Medical Ireland, Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.