510(k) Report

Devices descending from K143072

2 later devices reach ENROUTE Transcarotid Neuroprotection System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153485ENROUTE Transcarotid Neuroprotection SystemSilk Road Medical, Inc.20161Class I
+2K230402ENROUTE® Transcarotid Neuroprotection SystemSilk Road Medical20230Class I