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QEJClass II

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

21 CFR 876.4100 / Gastroenterology, Urology
FDA source (opens on fda.gov)

QEJ is the FDA product code for Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries, a class II device type, regulated under 21 CFR 876.4100. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QEJ
Device name
Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
FDA 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.
Regulation
21 CFR 876.4100
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code QEJ

By decision year
2 clearances under product code QEJ with a decision year between 2023 and 2024, 2023 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code QEJ by decision year
YearClearances
20231
20241

Applicants with the most clearances

Product code QEJ
Applicants holding the most 510(k) clearances under product code QEJ
ApplicantClearances
Marizyme, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code