Not Cleared Direct

DEN230002 - DuraGraft (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230002 · Marizyme, Inc. · Gastroenterology & Urology device
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Oct 2023
Decision
274d
Days
Class 2
Risk

DEN230002 is an FDA 510(k) submission (not cleared) for the DuraGraft. Classified as Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries (product code QEJ), Class II - Special Controls.

Submitted by Marizyme, Inc. (Jupiter, US). The FDA issued a Not Cleared (DENG) decision on October 4, 2023 after a review of 274 days.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.4100 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. Elevated predicate reliance profile. With 274 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN230002 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received January 03, 2023
Decision Date October 04, 2023
Days to Decision 274 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 130d · This submission: 274d
Pathway characteristics

Device Classification

Product Code QEJ Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.4100
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.