510(k) Report

Devices descending from K192360

2 later devices reach IntellaMap Orion High Resolution Mapping Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K220796IntellaMap Orion High Resolution Mapping CatheterBoston Scientific Corporation20220—
+1K211662Reprocessed IntellaMap Orion High Resolution Mapping CatheterInnovative Health, LLC20210—