21 CFR 876.4100 — Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
Gastroenterology, Urology (GU) · Subpart E—Surgical Devices · § 876.4100
Identification
A flushing and storage solution for vascular autografts at room temperature 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. The DuraGraft Vascular Conduit Solution is specifically indicated for adult patients undergoing Coronary Artery Bypass Grafting (CABG) surgeries and is intended for flushing and storage of the saphenous vein grafts from harvesting through grafting for up to 4 hours.
Classification Rationale
Class II (special controls). The device is granted under the De Novo process, and the risks are mitigated by general controls and the identified special controls.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| QEJ | Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries | 2 | 2 | Life-Sustaining |
Special Controls
QEJ — Flushing Solution For Short Term Storage Of Veins At Room Temperature During Coronary Artery Bypass Graft Surgeries
In combination with the general controls of the FD&C Act, the flushing and storage solution for vascular autografts at room temperature is subject to the following special controls:
De Novo Order DEN230002
