510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230002Unknown

DuraGraft

Marizyme, Inc., Jupiter FL / Direct, Unknown
FDA source (opens on fda.gov)

DEN230002 is the FDA 510(k) clearance record for DuraGraft, a class II device, cleared for Marizyme, Inc. on under FDA product code QEJ (Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries). FDA's definition for product code QEJ reads: "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...". FDA records list 2 510(k) clearances for Marizyme, Inc., from to . As of , FDA records show no recalls naming DEN230002.

Clearance record

Decision date
Received
(274 days to decision)
Product code
QEJ Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
Regulation
21 CFR 876.4100
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Marizyme, Inc. 555 Heritage Dr., Jupiter FL
Third party review
No

Clearances, product code QEJ

Trailing 12 months

FDA records hold no clearances under product code QEJ in the trailing twelve months.

FDA records show no clearances under product code QEJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QEJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260