FDA product code MFX: Vessel Guard Or Cover, To Facilitate Revision Surgeries
MFX is the FDA product code for vessel guard or cover, to facilitate revision surgeries. It is a Class II device, regulated under 21 CFR 870.3470 and reviewed by the Cardiovascular panel. FDA has cleared 2 510(k) submissions under MFX. The average 510(k) review took 78 days (median 78).
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.
Classification
| Field | Value |
|---|---|
| Device name | Vessel Guard Or Cover, To Facilitate Revision Surgeries |
| Device class | Class II |
| Regulation | 21 CFR 870.3470 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every MFX clearance
Top MFX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| W. L. Gore & Associates, Inc. | 2 | 2006-08-07 |
Most recent MFX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K061727 | W. L. Gore & Associates, Inc. | GORE PRECLUDE VESSEL GUARD | 2006-08-07 | 49 |
| K960532 | W. L. Gore & Associates, Inc. | PRECLUDE IMA SLEEVE | 1996-05-23 | 106 |
Recalls for MFX devices
openFDA lists no recalls for product code MFX.
Frequently asked questions
What is FDA product code MFX?
MFX is the FDA product code for vessel guard or cover, to facilitate revision surgeries. It is a Class II device, regulated under 21 CFR 870.3470 and reviewed by the Cardiovascular panel.
What device class is MFX?
Class II, regulation 21 CFR 870.3470. Typical premarket route: 510(k).
How long does a 510(k) take for product code MFX?
Across 2 cleared submissions the average was 78 days from receipt to decision (median 78).
Which companies have the most MFX clearances?
W. L. Gore & Associates, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code MFX
- Run a recall and safety report across every MFX manufacturer
- Watch product code MFX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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