K262086
- 510(k) number
- K262086
- Device name
- PreludeSYNC Radial Compression Device
- Applicant
- Merit Medical Systems, Inc. UT · US
- Product code
- DXC — Clamp, Vascular
- Decision date
- 2026-07-22
- Date received
- 2026-06-22
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K262086.pdf
Official FDA record: K262086
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.