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.
2
Total
1
Cleared
151d
Avg days
2023
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
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)
2 devices
Cleared
May 01, 2024
DuraGraft Vascular Conduit Solution
Marizyme
Gastroenterology & Urology
27d
Not Cleared
Oct 04, 2023
DuraGraft
Marizyme, Inc.
Gastroenterology & Urology
274d
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.