510(k) K233943

Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013) by Medtronic, Inc. — Product Code DQK

K233943 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)". The FDA issued a decision of Substantially Equivalent on March 8, 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.