510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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MFXClass II

Vessel Guard Or Cover, To Facilitate Revision Surgeries

21 CFR 870.3470 / Cardiovascular
FDA source (opens on fda.gov)

MFX is the FDA product code for Vessel Guard Or Cover, To Facilitate Revision Surgeries, a class II device type, regulated under 21 CFR 870.3470. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MFX
Device name
Vessel Guard Or Cover, To Facilitate Revision Surgeries
FDA 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.
Regulation
21 CFR 870.3470
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code MFX

By decision year
2 clearances under product code MFX with a decision year between 1996 and 2006, 1996 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MFX by decision year
YearClearances
19961
20061

Applicants with the most clearances

Product code MFX
Applicants holding the most 510(k) clearances under product code MFX
ApplicantClearances
W. L. Gore & Associates, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code