510(k) Report

Devices descending from K233943

5 later devices reach Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241828Affera Integrated Mapping System; Impedance Localization Patch KitMedtronic, Inc.20244—
+2K250747Globe® Pulsed Field SystemKardium, Inc.20250—
+2K243892Affera Integrated Mapping SystemMedtronic, Inc.20251—
+2K243435Magnetic Localization Patch Kit (AFR-00021)Medtronic, Inc.20240—
+3K262005Affera Integrated Mapping SystemMedtronic, Inc.20260—