510(k) Report

Devices descending from K092075

4 later devices reach CPS Direct SL II Slittable Outer Catheter, Models DS2C001, DS2C002, DS2C003… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130257CPS Direct Universal Slittable Outer CatheterSt Jude Medical20131—
+1K120296CPS Direct Mediguide Enabled Outer CatheterSt. Jude Medical, Cardiac Rhythm Management Divisi20121—
+2K231311CPS Direct™ Universal slittable outer guide catheter (DS2C029)Abbott Medical20230—
+2K142239CPS Direct MediGuide Enabled outer catheterSt Jude Medical20140—