510(k) Report

Devices descending from K210655

1 later device reach Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223026NES Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterNortheast Scientific, Inc.20230—