“PeriBeam” the Pericardial Membrane received FDA Clearance today.
510(k) # K240775
Trade/Device Name: PeriBeam Pericardial Membrane
Regulation Number: 21 CFR 870.3470
Regulation Name: Intracardiac Patch Or Pledget Made Of Polypropylene, Polyethylene Terephthalate, Or Polytetrafluoroethylene
Regulatory Class: Class II
Product Code: DXZ
