DEN230002
- 510(k) number
- DEN230002
- Device name
- DuraGraft
- Applicant
- Marizyme, Inc. FL · US
- Product code
- QEJ — Flushing Solution For Short Term Storage Of Veins At
- Decision date
- 2023-10-04
- Date received
- 2023-01-03
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Gastroenterology, Urology
Official FDA record: DEN230002
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.