DuraGraft Vascular Conduit Solution— 510(k) K240925
Substantially EquivalentMarizyme
FDA 510(k) clearance K240925 for DuraGraft Vascular Conduit Solution, Substantially Equivalent on 2024-05-01. Applicant: Marizyme. Device class: 2.
Clearance details
- Applicant
- Marizyme
- Product code
- Code QEJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.4100
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Jupiter, FL, US
Recent devices under product code QEJ
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