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DuraGraft Vascular Conduit Solution

by Marizyme

510(k) K240925

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK240925 Date1 May 2024ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QEJ
Device Class
Class II
Regulation
21 CFR Part 876.4100
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The DuraGraft Vascular Conduit Solution is a flushing solution for short term storage of veins at room temperature during coronary artery bypass graft surgeries. It is used for flushing and storage of vascular grafts, maintaining cell viability and structural integrity during short-term storage. The solution is clear, colorless to slightly yellow, and is aseptically processed and non-pyrogenic.

The DuraGraft Vascular Conduit Solution is supplied as a solution for room temperature flushing and storage of vascular conduits. It has an FDA 510K authorization and is classified as a class 2 device. The solution is intended for use in adult patients undergoing coronary artery bypass grafting surgeries, and is used for up to 4 hours from harvesting through grafting.

Other devices from Marizyme

  • DuraGraft

    Class II

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the DuraGraft Vascular Conduit Solution used for?

    The DuraGraft Vascular Conduit Solution is used for flushing and storage of vascular grafts, maintaining cell viability and structural integrity during short-term storage, specifically in coronary artery bypass graft surgeries.

  • How is the DuraGraft Vascular Conduit Solution supplied?

    The solution is supplied as a clear, colorless to slightly yellow solution, aseptically processed and non-pyrogenic, for room temperature flushing and storage of vascular conduits.

  • What is the intended use duration of the DuraGraft Vascular Conduit Solution?

    The solution is intended for use in adult patients undergoing coronary artery bypass grafting surgeries, for up to 4 hours from harvesting through grafting.

  • Is the DuraGraft Vascular Conduit Solution sterile?

    Yes, the DuraGraft Vascular Conduit Solution is aseptically processed, indicating it is supplied in a sterile condition.