QEJ
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.4100
- Medical specialty
- Gastroenterology, Urology
- Flags
- Life-sustaining
- 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| DuraGraft Vascular Conduit Solution (K240925) | Marizyme | 2024-05-01 | + Add |
| DuraGraft (DEN230002) | Marizyme, Inc. | 2023-10-04 |
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Every clearance here is in the API, with alerts when new ones post.