510(k) K201449

SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring by Medtronic, Inc. — Product Code KRH

K201449 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring". The FDA issued a decision of Substantially Equivalent on July 1, 2020. The device falls under product code KRH (Ring, Annuloplasty), a Class II device regulated under 21 CFR 870.3800. Medtronic, Inc. has at least 10 other 510(k) clearances on record.