# K240925: DuraGraft Vascular Conduit Solution

- Pathway: 510(k) (Special)
- Applicant: Marizyme
- Decided: May 1, 2024 after 27 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
Longest line of descent: 1 generation back to DEN230002 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230002: DuraGraft, Marizyme, Inc. (2023) Summary page 4.

## 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/K240925
Methodology: https://510kreport.com/methodology