Vessel Guard Or Cover, To Facilitate Revision Surgeries
The vessel guard or cover is a cardiovascular device used to wrap, patch, or protect blood vessels from injury during cardiac surgery, with the secondary function of providing a plane of dissection to facilitate revision surgeries in patients who require reoperation. It is classified as FDA Class II under 21 CFR 870.3470 within the Cardiovascular specialty, requiring 510(k) premarket clearance. The product code is MFX and the device is not flagged as an implant in this classification. Full GMP quality system requirements apply.
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Basic Information
- Product Code
- MFX
- Device Class
- FDA class 2
- Regulation Number
- 870.3470
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.