510(k) K240925
- Device
- DuraGraft Vascular Conduit Solution
- Applicant
- Marizyme
- 510(k) number
- K240925
- Product code
- QEJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-05-01
- Date received
- 2024-04-04
- Regulation
- 876.4100
- Classification name
- Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Catherine Pachuk
- Address
- 555 Heritage Dr. Suite 205 Jupiter FL US 33458 33458
FDA Registration Numbers
- 3013508066
- 3011421726
Source Documents
Other 510(k) Records For Product Code QEJ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| DEN230002 | DuraGraft | Marizyme, Inc. | 2023-10-04 |