K252027
- 510(k) number
- K252027
- Device name
- Vertex(TM) Catheter
- Applicant
- Jupiter Endovascular CA · US
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2025-09-12
- Date received
- 2025-06-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K252027.pdf
Official FDA record: K252027
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.