510(k) K262005

Affera Integrated Mapping System by Medtronic, Inc. — Product Code DQK

K262005 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Affera Integrated Mapping System". The FDA issued a decision of Substantially Equivalent on August 21, 2026. 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.