DeviceClearance

Product code MFX— Cardiovascular

GORE PRECLUDE VESSEL GUARD

Classification name
Vessel Guard Or Cover, To Facilitate Revision Surgeries
Device class
Class 2
Regulation
21 CFR 870.3470
Advisory panel
Cardiovascular
Total cleared
2
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code MFX under 21 CFR 870.3470, via openFDA

Market context for product code MFX

FDA has cleared 2 devices under product code MFX between 1996 and 2006, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code MFX

Recent clearances under product code MFX

Data sourced from openFDA. This site is unofficial and independent of the FDA.