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

FDA Device Classification

Classification Details

Product Code
QEJ
Device Class
Class II
Regulation Number
876.4100
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

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.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K240925marizymeDuraGraft Vascular Conduit SolutionMay 1, 2024
DEN230002marizymeDuraGraftOctober 4, 2023