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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Marizyme. It received FDA 510(k) clearance on 2024-05-01 under 510(k) 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. The listed applicant is Marizyme. The 510(k) number is K240925.

When did DuraGraft Vascular Conduit Solution receive FDA 510(k) clearance?

DuraGraft Vascular Conduit Solution received FDA 510(k) clearance on 2024-05-01, under 510(k) number K240925.

Who is the listed applicant for DuraGraft Vascular Conduit Solution?

The FDA 510(k) record lists Marizyme as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DuraGraft Vascular Conduit Solution?

The FDA product code for DuraGraft Vascular Conduit Solution is QEJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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