Vessel Guard Or Cover, To Facilitate Revision Surgeries

MFX · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.3470

Classification

FDA Product Code: MFX
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.3470
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 2
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown