DuraGraft Vascular Conduit Solution
K-Number: K240925 · 2024-05-01
ApplicantMarizyme
Decision Date2024-05-01
Product CodeQEJ
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
DuraGraft Vascular Conduit Solution is a medical device manufactured by Marizyme. It received FDA 510(k) clearance on 2024-05-01 under approval number K240925. The device is classified under product code QEJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DuraGraft Vascular Conduit Solution?
DuraGraft Vascular Conduit Solution is a medical device that received FDA 510(k) clearance on 2024-05-01. It is manufactured by Marizyme. The 510(k) number is K240925.
When was DuraGraft Vascular Conduit Solution approved by the FDA?
DuraGraft Vascular Conduit Solution received FDA 510(k) clearance on 2024-05-01, under approval number K240925.
What company makes DuraGraft Vascular Conduit Solution?
DuraGraft Vascular Conduit Solution is manufactured by Marizyme.
What is the FDA product code for DuraGraft Vascular Conduit Solution?
The FDA product code for DuraGraft Vascular Conduit Solution is QEJ.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.