DuraGraft Vascular Conduit Solution
FDA 510(k) clearance K240925 · decided 2024-05-01
Clearance details
- K-number
- K240925
- Device name
- DuraGraft Vascular Conduit Solution
- Applicant
- Marizyme
- Decision
- Substantially Equivalent
- Date received
- 2024-04-04
- Decision date
- 2024-05-01
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- QEJ
- Device class
- 2
- Regulation number
- 876.4100
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Jupiter, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DuraGraft (DEN230002) | Marizyme, Inc. | 2023-10-04 |
Recalls involving this device
No recalls on record reference this clearance.