K252445
- 510(k) number
- K252445
- Device name
- Fusion Bioline Vascular Graft
- Applicant
- Maquet Cardiovascular, LLC NJ · US
- Product code
- DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diame
- Decision date
- 2026-04-27
- Date received
- 2025-08-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252445.pdf
Official FDA record: K252445
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.