510(k) K112771

BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG by Sorin Group Italia S.R.L. — Product Code DTN

K112771 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG". The FDA issued a decision of Substantially Equivalent on October 14, 2011. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Sorin Group Italia S.R.L. has at least 10 other 510(k) clearances on record.