InQwire Amplatz Guide Wire— 510(k) K254137
Substantially EquivalentMerit Medical Ireland, Ltd.
FDA 510(k) clearance K254137 for InQwire Amplatz Guide Wire, Substantially Equivalent on 2026-05-22. Applicant: Merit Medical Ireland, Ltd.. Device class: 2.
Summary
Merit Medical Ireland's InQwire Amplatz Guide Wire is filed under DQX, catheter guide wires.
Class II, 21 CFR 870.1330. Cardiovascular is both the classification panel and the review panel, and it was a Traditional 510(k).
Merit filed from Galway, Ireland. Review took 151 calendar days (December 22, 2025 to May 22, 2026).
Clearance details
- Applicant
- Merit Medical Ireland, Ltd.
- Product code
- Product code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Galway, IE
Recent devices under product code DQX
view allMore clearances from Merit Medical Ireland, Ltd.
view allAdverse 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, through . 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.