DuraGraft
FDA 510(k) clearance DEN230002 · decided 2023-10-04
Clearance details
- K-number
- DEN230002
- Device name
- DuraGraft
- Applicant
- Marizyme, Inc.
- Decision
- Unknown
- Date received
- 2023-01-03
- Decision date
- 2023-10-04
- Days to decision
- 274 days
- Clearance type
- Direct
- 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 Vascular Conduit Solution (K240925) | Marizyme | 2024-05-01 |
Recalls involving this device
No recalls on record reference this clearance.