510(k) Report

Devices descending from K122461

4 later devices reach Rhythmia Mapping Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143481IntellaMap Orion High Resolution Mapping CatheterRhythmia Medical, Inc.20153—
+2K192360IntellaMap Orion High Resolution Mapping CatheterBoston Scientific Corporation20192—
+3K220796IntellaMap Orion High Resolution Mapping CatheterBoston Scientific Corporation20220—
+3K211662Reprocessed IntellaMap Orion High Resolution Mapping CatheterInnovative Health, LLC20210—