MFX — Vessel Guard Or Cover, To Facilitate Revision Surgeries Class II
FDA product code MFX covers "Vessel Guard Or Cover, To Facilitate Revision Surgeries", a Class II medical device regulated under 21 CFR 870.3470. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- MFX
- Device Class
- Class II
- Regulation Number
- 870.3470
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
Wrap, patch, or cover intended to protect vessels from injury during surgery, with the secondary function of facilitating revision surgeries by providing a plane of dissection.