Pericardial Patch To Facilitate Revision Surgeries

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

Classification

FDA Product Code: OMH
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: Y
Implant: Y
Third-party review: N

Definition

Pericardial patch or pledget with the secondary function of facilitating revision surgeries by providing a plane of dissection. Does not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of cardiac surgery.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 3

Source

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