510(k) K925661

STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE by Sorin Biomedica, Fiat, USA, Inc. — Product Code KRL

K925661 is an FDA 510(k) premarket notification submitted by Sorin Biomedica, Fiat, USA, Inc. for the device "STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE". The FDA issued a decision of Substantially Equivalent on May 18, 1993. The device falls under product code KRL (Detector, Bubble, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4205. Sorin Biomedica, Fiat, USA, Inc. has at least 10 other 510(k) clearances on record.