K254137
- 510(k) number
- K254137
- Device name
- InQwire Amplatz Guide Wire
- Applicant
- Merit Medical Ireland, Ltd. IE
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2026-05-22
- Date received
- 2025-12-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.0 MB · U.S. public domain
Also available from FDA: K254137.pdf
Official FDA record: K254137
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.