K241550
- 510(k) number
- K241550
- Device name
- Gelweave Vascular Prostheses
- Applicant
- Vascutek, Ltd. GB
- Product code
- DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diame
- Decision date
- 2025-02-27
- Date received
- 2024-05-31
- 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: K241550.pdf
Official FDA record: K241550
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.