510(k) K240925
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 2024
- Date Received
- April 4, 2024
- Clearance Type
- Special
- 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.