510(k) DEN230002
DEN230002 is an FDA 510(k) premarket notification submitted by Marizyme, Inc. for the device "DuraGraft". The FDA issued a decision of De Novo Granted on October 4, 2023. The device falls under product code QEJ (Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries), a Class II device regulated under 21 CFR 876.4100. Marizyme, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- October 4, 2023
- Date Received
- January 3, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
- Device Class
- Class II
- Regulation Number
- 876.4100
- Review Panel
- GU
- Submission Type
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.