Skip to contentDe Novo DEN230002
- Device
- DuraGraft
- Contact
- navdeep kaur cheema
- De Novo number
- DEN230002
- Product code
- QEJ
- Regulation
- 876.4100
- Classification name
- flushing solution for short term storage of veins at room temperature during coronary artery bypass graft surgeries
- Decision
- granted (DENG)
- Decision date
- 2023-10-04
- Date received
- 2023-01-03
- Classification advisory
- Gastroenterology/Urology
- Review advisory
- Gastroenterology/Urology
- Type
- Direct
Current FDA Classification#
- Product code
- QEJ
- Device name
- Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation
- 876.4100
- Implant
- N
- Life sustain/support
- Y