510(k) K851365

SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM by Sorin Biomedica, Fiat, USA, Inc. — Product Code DXY

K851365 is an FDA 510(k) premarket notification submitted by Sorin Biomedica, Fiat, USA, Inc. for the device "SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM". The FDA issued a decision of Substantially Equivalent on December 3, 1985. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Sorin Biomedica, Fiat, USA, Inc. has at least 10 other 510(k) clearances on record.