510(k) K093858

PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A by St. Jude Medical, Cardiac Rhythm Management Divisi — Product Code DSA

K093858 is an FDA 510(k) premarket notification submitted by St. Jude Medical, Cardiac Rhythm Management Divisi for the device "PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A". The FDA issued a decision of Substantially Equivalent on April 2, 2010. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. St. Jude Medical, Cardiac Rhythm Management Divisi has at least 9 other 510(k) clearances on record.