K240871
- 510(k) number
- K240871
- Device name
- Synxess Neurovascular Guidewire
- Applicant
- Enlight Medical Technologies (Shenzhen) Co., Ltd. CN
- Product code
- MOF — Guide, Wire, Catheter, Neurovasculature
- Decision date
- 2024-11-18
- Date received
- 2024-03-29
- 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: K240871.pdf
Official FDA record: K240871
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.