K253847
- 510(k) number
- K253847
- Device name
- Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
- Applicant
- Merit Medical Ireland, Ltd. IE
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2026-01-31
- Date received
- 2025-12-02
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K253847.pdf
Official FDA record: K253847
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.