510(k) K904556

MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB by Boston Scientific Corp — Product Code IOL

K904556 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB". The FDA issued a decision of Substantially Equivalent on December 18, 1991. The device falls under product code IOL (Treadmill, Powered), a Class I device regulated under 21 CFR 890.5380. Boston Scientific Corp has at least 10 other 510(k) clearances on record.