K243733
- 510(k) number
- K243733
- Device name
- SION blue PLUS
- Applicant
- Asahi Intecc Co., Ltd. JP
- Product code
- DQX — Wire, Guide, Catheter
- Decision date
- 2025-04-02
- Date received
- 2024-12-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K243733.pdf
Official FDA record: K243733
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.