510(k) K241828

Affera Integrated Mapping System; Impedance Localization Patch Kit by Medtronic, Inc. — Product Code DQK

K241828 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Affera Integrated Mapping System; Impedance Localization Patch Kit". The FDA issued a decision of Substantially Equivalent on November 1, 2024. The device falls under product code DQK (Computer, Diagnostic, Programmable), a Class II device regulated under 21 CFR 870.1425. Medtronic, Inc. has at least 10 other 510(k) clearances on record.