K253847

Substantially Equivalent

Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)

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

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.