510(k) Report

Devices descending from K163380

2 later devices reach Serranator Alto PTA Serration Balloon Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213728Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20211—
+2K220704Serranator PTA Serration Balloon CatheterCagent Vascular, LLC20220—