# DEN230002: DuraGraft

- Pathway: De Novo (Direct)
- Applicant: Marizyme, Inc.
- Decided: Oct 4, 2023 after 274 days
- Product code: QEJ (Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries)
- Device class: 2
- Regulation: 21 CFR 876.4100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K240925: DuraGraft Vascular Conduit Solution (2024), 0 descendants of its own

## Indications for use
DuraGraft Vascular Conduit Solution is a solution indicated for adult patients undergoing Coronary Artery Bypass Grafting Surgeries and is intended for flushing and storage of the saphenous vein grafts from harvesting through grafting for up to 4 hours.

Source page: https://510kreport.com/device/DEN230002
Methodology: https://510kreport.com/methodology