K243061
- 510(k) number
- K243061
- Device name
- SonoStik Guide Wire Introducer
- Applicant
- Sonostik, LLC OH · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2024-11-04
- Date received
- 2024-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain
Also available from FDA: K243061.pdf
Official FDA record: K243061
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.