510(k) Report

Devices descending from K153617

5 later devices reach OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K173820OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz…Boston Scientific Corporation20183—
+1K161125OptiCross X, 40 MHz Coronary Imaging CatheterBoston Scientific Corporation20160—
+2K213593OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HDBoston Scientific Corporation202221
+3K230453OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging CatheterBoston Scientific Corporation20231—
+4K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter…Boston Scientific20260—