K231972
- 510(k) number
- K231972
- Device name
- Advanta VXT Vascular Graft, Flixene Vascular Graft
- Applicant
- Atrium Medical Corporation NH · US
- Product code
- DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diame
- Decision date
- 2024-03-28
- Date received
- 2023-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K231972.pdf
Official FDA record: K231972
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.