K241521
- 510(k) number
- K241521
- Device name
- Prelude Small O.D. Introducer Guide Wire
- Applicant
- Merit Medical Systems, Inc. UT · US
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2024-12-10
- Date received
- 2024-05-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K241521.pdf
Official FDA record: K241521
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.