510(k) K142221

MEMO 3D ReChord by Sorin Group Italia S.R.L. — Product Code KRH

K142221 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "MEMO 3D ReChord". The FDA issued a decision of Substantially Equivalent on August 29, 2014. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Sorin Group Italia S.R.L. has at least 10 other 510(k) clearances on record.