510(k) Report

Devices descending from K241828

4 later devices reach Affera Integrated Mapping System; Impedance Localization Patch Kit through their predicates, nearest generation first.

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