510(k) K240925
K240925 is an FDA 510(k) premarket notification submitted by Marizyme for the device "DuraGraft Vascular Conduit Solution". The FDA issued a decision of Substantially Equivalent on May 1, 2024. 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 has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 1, 2024
- Date Received
- April 4, 2024
- Clearance Type
- Special
- 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.