510(k) Report

Devices descending from K952638

12 later devices reach 4.5F Imagecath Coronary Angioscope, Model COV45 [Subsequently Referred to as… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253842Vena MicroAngioscope™ SystemVena Medical Holdings Corp20260—
+1K042381Coronary Sinus Visualization System, Model CSVS5508Acumen Medical, Inc.20043—
+1K023548Proxis Flow-Control Device, Models Eps 101, IC 101Velocimed20036—
+2K070051Acumen Insight Endocardial Visualization SystemAcumen Medical, Inc.20070—
+2K050808Coronary Sinus Access Kit, Model KCS8F-01Cardio-Optics, Inc.20051—
+2K042117Proxis System, Model Eps 101Velocimed, Inc.20055—
+3K063638Modification to Proxis System, Model Eps 101St Jude Medical20071—
+3K062340Cardiooptics Augmentative Cardiac Optical Imaging SystemCardio-Optics, Inc.20060—
+3K060651Proxis System, Model EPS101St Jude Medical20063—
+3K052523Proxis SystemVelocimed, Inc.20062—
+4K0737006F Proxis SystemSt. Jude Medical, Inc.20080—
+4K073563Modification to Proxis SystemSt Jude Medical20080—