K240925 is an FDA 510(k) clearance for the DuraGraft Vascular Conduit Solution. 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 (Jupiter, US). The FDA issued a Cleared decision on May 1, 2024, 27 days after receiving the submission on April 4, 2024.
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 | K240925 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 04, 2024 |
| Decision Date | May 01, 2024 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| 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. |