510(k) K211100

AcQGuide MAX Steerable Sheath by Acutus Medical, Inc. — Product Code DRA

K211100 is an FDA 510(k) premarket notification submitted by Acutus Medical, Inc. for the device "AcQGuide MAX Steerable Sheath". The FDA issued a decision of Substantially Equivalent on May 14, 2021. The device falls under product code DRA (Catheter, Steerable), a Class II device regulated under 21 CFR 870.1280. Acutus Medical, Inc. has at least 10 other 510(k) clearances on record.