Go2Wire Guide Wire— 510(k) K193571

Clearance details

Applicant

Merit Medical System, Inc.

Product code

Code DQX

Device class

Class 2

Regulation

21 CFR 870.1330

Advisory panel

Cardiovascular

Date received

2019-12-23

Decision date

2020-04-08

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Galway, IE

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• K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more2026-03-20

• K252527 — Surfacer Inside-Out Access Catheter System2025-09-10
• K231468 — SCOUT MD Surgical Guidance System2024-02-12
• K230636 — Maestro Microcatheter2023-03-30
• K212817 — Merit Siege Vascular Plug2021-12-15

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 →