DEN230002 is an FDA 510(k) submission for the DuraGraft. This device is classified as a Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries (Class II - Special Controls, product code QEJ).
Submitted by Marizyme, Inc. (Jupiter, US). The FDA issued a Not Cleared (DENG) decision on October 4, 2023.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4100. 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..
| 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 | - |
| Product Code | QEJ - Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries |
| Device Class | Class II - 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. |