K243383
- 510(k) number
- K243383
- Device name
- CHIKAI Nexus 014
- Applicant
- Asahi Intecc Co., Ltd. JP
- Product code
- MOF — Guide, Wire, Catheter, Neurovasculature
- Decision date
- 2025-04-21
- Date received
- 2024-10-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K243383.pdf
Official FDA record: K243383
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.