K261640
- 510(k) number
- K261640
- Device name
- Merit MAK Nitinol/Gold-Tungsten Guide Wire
- Applicant
- Merit Medical Ireland , Ltd. IE
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2026-07-13
- Date received
- 2026-05-18
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K261640.pdf
Official FDA record: K261640
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.