MFX
2 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Vessel Guard Or Cover, To Facilitate Revision Surgeries
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3470
- Medical specialty
- Cardiovascular
- 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.
- Adverse events (MAUDE)
- 1997: 4 · 1999: 2 · 2000: 9 · 2003: 2 · 2007: 3 · 2008: 7
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| GORE PRECLUDE VESSEL GUARD (K061727) | W. L. Gore & Associates, Inc. | 2006-08-07 |
| PRECLUDE IMA SLEEVE (K960532) | W. L. Gore & Associates, Inc. | 1996-05-23 |
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Every clearance here is in the API, with alerts when new ones post.