510(k) K221464

CorPath GRX System by Corindus, Inc. — Product Code DXX

K221464 is an FDA 510(k) premarket notification submitted by Corindus, Inc. for the device "CorPath GRX System". The FDA issued a decision of Substantially Equivalent on July 27, 2022. The device falls under product code DXX (System, Catheter Control, Steerable), a Class II device regulated under 21 CFR 870.1290. Corindus, Inc. has at least 8 other 510(k) clearances on record.