K243938
- 510(k) number
- K243938
- Device name
- Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire
- Applicant
- Scientia Vascular, Inc. UT · US
- Product code
- MOF — Guide, Wire, Catheter, Neurovasculature
- Decision date
- 2025-04-01
- Date received
- 2024-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K243938.pdf
Official FDA record: K243938
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.