510(k) Report

Devices descending from K123621

8 later devices reach Opticross 40 MHZ Coronary Imaging Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250751DualView CatheterTerumo Corporation20250—
+1K173284OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz…Boston Scientific Corporation20173—
+1K153617OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz…Boston Scientific Corporation20165—
+2K213593OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HDBoston Scientific Corporation202221
+2K173820OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz…Boston Scientific Corporation20183—
+2K161125OptiCross X, 40 MHz Coronary Imaging CatheterBoston Scientific Corporation20160—
+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—