510(k) K852641

ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER by Sorin Biomedica, Fiat, USA, Inc. — Product Code DXY

K852641 is an FDA 510(k) premarket notification submitted by Sorin Biomedica, Fiat, USA, Inc. for the device "ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER". The FDA issued a decision of Substantially Equivalent on January 14, 1986. 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.