K250909
- 510(k) number
- K250909
- Device name
- Prelude Wave Hydrophilic Sheath Introducer
- Applicant
- Merit Medical Systems, Inc. UT · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2025-04-25
- Date received
- 2025-03-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K250909.pdf
Official FDA record: K250909
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.