510(k) K180411

MEMO 4D by Sorin Group Italia S.R.L. — Product Code KRH

K180411 is an FDA 510(k) premarket notification submitted by Sorin Group Italia S.R.L. for the device "MEMO 4D". The FDA issued a decision of Substantially Equivalent on March 16, 2018. 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.