Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)— 510(k) K253847

Substantially Equivalent

Merit Medical Ireland, Ltd.

FDA 510(k) clearance K253847 for Splashwire Hydrophilic Guide Wire (MSWSTD35150J3), Substantially Equivalent on 2026-01-31. Applicant: Merit Medical Ireland, Ltd..

Clearance details

Applicant: Merit Medical Ireland, Ltd.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 2025-12-02
Decision date: 2026-01-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.