FDA Product Code QEJ: Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
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.
Leading manufacturers include Marizyme, Inc. and Marizyme.
FDA 510(k) Cleared Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries Devices (Product Code QEJ)
About Product Code QEJ - Regulatory Context
510(k) Submission Activity
2 total 510(k) submissions under product code QEJ since 2023, with 1 receiving FDA clearance (average review time: 151 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
QEJ devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →