510(k) Report

Devices descending from K213593

2 later devices reach OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230453OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging CatheterBoston Scientific Corporation20231—
+2K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter…Boston Scientific20260—