510(k) K193509

AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX by Acutus Medical, Inc. — Product Code DYB

K193509 is an FDA 510(k) premarket notification submitted by Acutus Medical, Inc. for the device "AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX". The FDA issued a decision of Substantially Equivalent on January 17, 2020. 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.