510(k) Report

Devices descending from K902245

2 later devices reach Sonicath (TM) 9F, 12 MHZ through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181042Ultra ICE Plus – PI 9 MHz Peripheral Imaging CatheterBoston Scientific Corporation20180—
+1K160173Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (eDFU), Ultra ICE Plus 9 MHz…Boston Scientific Corporation20160—