Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
The Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries is a device used for flushing or short-term storage of vascular autografts during surgical procedures, intended to maintain cell viability and structural integrity of vascular grafts at room temperature. It is classified as FDA Class 2, requiring 510(k) premarket notification under regulation 876.4100 in the Gastroenterology and Urology specialty. The product code is QEJ. This device carries a life-sustaining/life-supporting flag.
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Basic Information
- Product Code
- QEJ
- Device Class
- FDA class 2
- Regulation Number
- 876.4100
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- GU
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.