510(k) Report

Devices descending from K983534

4 later devices reach 7F Hydrolyser Thrombectomy Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041705Resolution Thrombectomy System, Model EV-2Omnisonics Medical Technologies20043—
+2K052428Resolution Endovascular SystemOmnisonics Medical Technologies20052—
+3K071762Omniwave Endovascular SystemOmnisonics Medical Technologies20071—
+4K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies20080—