“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
For further details, please contact:
TamaBio Company LimitedHead Office : 402 Gran Creste 2-2-18 Sakai Musashino-shi Tokyo 180-0022 Japan Medical device manufacturing / Class 1 manufacturing and sales DevelopmentManufacturing, and sales of Class IV highly controlled medical devicesDevelopment, manufacturing, and sales of regenerative medical devices and other synthetic artificial biomembranes Managing Director / CEO : Tetsuya Nagao