FDA Product Code
FDA Product Code QEJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.4100
510(k) Clearances — 2 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K240925 | DuraGraft Vascular Conduit Solution | Marizyme | 2024-05-01 | Special | PDF ↗ |
| DEN230002 | DuraGraft | Marizyme, Inc. | 2023-10-04 | Direct | — |
Product code QEJ · Class II · Gastroenterology, Urology. Data: openFDA.