510(k) DEN230002
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 4, 2023
- Date Received
- January 3, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
- Device Class
- Class II
- Regulation Number
- 876.4100
- Review Panel
- GU
- Submission Type
A flushing and storage solution for vascular autografts is a device that is used for flushing or short-term storage of vascular grafts. This generic type of device is intended to maintain cell viability and structural integrity of vascular grafts during short-term storage at room temperature during the surgical procedure.