510(k) Report

Devices descending from K143481

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192360IntellaMap Orion High Resolution Mapping CatheterBoston Scientific Corporation20192—
+2K220796IntellaMap Orion High Resolution Mapping CatheterBoston Scientific Corporation20220—
+2K211662Reprocessed IntellaMap Orion High Resolution Mapping CatheterInnovative Health, LLC20210—