510(k) K233691

FlexCath Cross Transseptal Solution by Acutus Medical, Inc. — Product Code DYB

K233691 is an FDA 510(k) premarket notification submitted by Acutus Medical, Inc. for the device "FlexCath Cross Transseptal Solution". The FDA issued a decision of Substantially Equivalent on December 17, 2023. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Acutus Medical, Inc. has at least 10 other 510(k) clearances on record.