K240925
- 510(k) number
- K240925
- Device name
- DuraGraft Vascular Conduit Solution
- Applicant
- Marizyme FL · US
- Product code
- QEJ — Flushing Solution For Short Term Storage Of Veins At
- Decision date
- 2024-05-01
- Date received
- 2024-04-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K240925.pdf
Official FDA record: K240925
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.