510(k) K210685

AcQCross Qx Integrated Transseptal Dilator/Needle by Acutus Medical, Inc. — Product Code DYB

K210685 is an FDA 510(k) premarket notification submitted by Acutus Medical, Inc. for the device "AcQCross Qx Integrated Transseptal Dilator/Needle". The FDA issued a decision of Substantially Equivalent on April 6, 2021. 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.