Merit MAK Nitinol/Gold-Tungsten Guide Wire— 510(k) K261640
Substantially EquivalentMerit Medical Ireland , Ltd.
FDA 510(k) clearance K261640 for Merit MAK Nitinol/Gold-Tungsten Guide Wire, Substantially Equivalent on 2026-07-13. Applicant: Merit Medical Ireland , Ltd.. Device class: 2.
Summary
Merit Medical Ireland's Merit MAK Nitinol/Gold-Tungsten Guide Wire is filed under DQX, catheter guide wires. The materials come from the device name, and the record doesn't give lengths or diameters.
Class II, 21 CFR 870.1330. Cardiovascular is both the classification panel and the review panel. It came in as a Special 510(k).
Merit Medical Ireland filed from Galway, Ireland. Review took 56 calendar days (May 18 to July 13, 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
- Special
- 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.