K252277
- 510(k) number
- K252277
- Device name
- Spiral Laminar Flow Vascular Arteriovenous Graft (AV0645)
- Applicant
- Vascular Flow Technologies Limited GB
- Product code
- DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diame
- Decision date
- 2025-10-20
- Date received
- 2025-07-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.1 MB · U.S. public domain
Also available from FDA: K252277.pdf
Official FDA record: K252277
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.