K243928
- 510(k) number
- K243928
- Device name
- ViaOne Epicardial Access System
- Applicant
- Cardiovia , Ltd. IL
- Product code
- DYB — Introducer, Catheter
- Decision date
- 2025-03-20
- Date received
- 2024-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K243928.pdf
Official FDA record: K243928
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.