510(k) Report

Devices descending from K063312

13 later devices reach Modification to Atlantis SR Pro 2 and SR Pro Coronary Imaging Catheters, Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111043Atlantis SR PRO2 Coronary Imaging Catheter, Icross Coronary Imaging CatheterBoston Scientific Corp20119—
+1K073623Atlantis 018 Peripheral Imaging CatheterBoston Scientific Corp20082—
+2K160514OptiCross 18, 30 MHz Peripheral Imaging CatheterBoston Scientific Corporation20161—
+2K123621Opticross 40 MHZ Coronary Imaging CatheterBoston Scientific Corp201381
+3K250751DualView CatheterTerumo Corporation20250—
+3K222568OptiCross™ 18 Peripheral Imaging CatheterBoston Scientific Corporation20220—
+3K173284OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz…Boston Scientific Corporation20173—
+3K153617OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz…Boston Scientific Corporation20165—
+4K213593OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HDBoston Scientific Corporation202221
+4K173820OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz…Boston Scientific Corporation20183—
+4K161125OptiCross X, 40 MHz Coronary Imaging CatheterBoston Scientific Corporation20160—
+5K230453OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging CatheterBoston Scientific Corporation20231—
+6K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter…Boston Scientific20260—