510(k) K161733

INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C by Sorin Group Italia S.R.L. — Product Code DTN

K161733 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C". The FDA issued a decision of Substantially Equivalent on March 8, 2017. 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.