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Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries

FDA product code QEJ · 1 cleared devices

Class 2 Gastroenterology, Urology
Regulation
21 CFR 876.4100
Review panel
GU
Implant
No
Life sustaining
Yes
Third party review
No
GMP exempt
No
Clearance span
2024-05-01 – 2024-05-01

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.

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