Splashwire Hydrophilic Guide Wire (6 models)— 510(k) K251181

Clearance details

Device name as filed

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.

Product code

Code DQX

Device class

Class 2

Regulation

21 CFR 870.1330

Advisory panel

Cardiovascular

Date received

2025-04-16

Decision date

2025-08-29

Decision

Substantially Equivalent

Clearance type

Special

Location

Galway, IE

• K261281 — CROSSLEAD Standard 035 and CROSSLEAD Stiff 0352026-09-03
• K253667 — Accoat Guide Wire2026-07-14
• K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire2026-07-13
• K254137 — InQwire Amplatz Guide Wire2026-05-22
• K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

• K253847 — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)2026-01-31
• K251385 — InQwire Super Stiff Guide Wire (6 models)2026-01-21
• K122321 — BASIXCONPAK ANALOG INFLATION SYRINGE2012-12-19

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 →