510(k) K230884

AVVIGO'+ Multi-Modality Guidance System by Boston Scientific Corporation — Product Code DQK

K230884 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "AVVIGO'+ Multi-Modality Guidance System". The FDA issued a decision of Substantially Equivalent on September 26, 2023. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.