K251181

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)

510(k) number: K251181
Device name: 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. IE
Product code: DQX — Wire, Guide, Catheter
Decision date: 2025-08-29
Date received: 2025-04-16
Decision: Substantially Equivalent
Clearance type: Special
Advisory committee: Cardiovascular

PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain

Also available from FDA: K251181.pdf

Official FDA record: K251181

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.