510(k) DEN230002
- Device
- DuraGraft
- Applicant
- Marizyme, Inc.
- 510(k) number
- DEN230002
- Product code
- QEJ
- Decision
- Unknown (DENG)
- Decision date
- 2023-10-04
- Date received
- 2023-01-03
- 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
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Navdeep Kaur Cheema
- Address
- 555 Heritage Dr. Suite 205 Jupiter FL US 33458 33458
FDA Registration Numbers
- 3013508066
- 3011421726
Source Documents
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QEJ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240925 | DuraGraft Vascular Conduit Solution | Marizyme | 2024-05-01 |