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FDA 510(k)

Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)

K-Number: K253847 · 2026-01-31

ApplicantMerit Medical Ireland, Ltd.
Decision Date2026-01-31
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) is a medical device manufactured by Merit Medical Ireland, Ltd.. It received FDA 510(k) clearance on 2026-01-31 under approval number K253847. 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 Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)?

Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) is a medical device that received FDA 510(k) clearance on 2026-01-31. It is manufactured by Merit Medical Ireland, Ltd.. The 510(k) number is K253847.

When was Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) approved by the FDA?

Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) received FDA 510(k) clearance on 2026-01-31, under approval number K253847.

What company makes Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)?

Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) is manufactured by Merit Medical Ireland, Ltd..

What is the FDA product code for Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)?

The FDA product code for Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) is DQX.

Other Devices by Merit Medical Ireland, Ltd.

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) 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)

Related Devices (Code: DQX)

K160785Worker GuidewireArgon Medical Devices, Inc. K161702Endura guidewireVascular Solutions, Inc. K160594MRWire Guide WireNano4imaging GmbH K160643ENROUTE 0.014 GuidewireLake Region Medical K153685Sunmed Haemostatic ValvesSunny Medical Device (Shenzhen) Co., Ltd. K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd.

Official Source

View on FDA Database →

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

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