510(k) Report

Devices descending from K924163

10 later devices reach Explorer/360-Polaris-L.E./Jackman Coron Sinus Elec through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230503Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter CableBoston Scientific20230—
+1K160303Reprocessed Polaris X Steerable Diagnostic EP CatheterInnovative Health, LLC20160—
+1K052414Reprocessed Electrophysiology CatheterAlliance Medical Corp.20050—
+1K043393Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp.20051—
+1K023180Vanguard Reprocessed Diagnostic Electrophysiology CathetersVanguard Medical Concepts, Inc.20021—
+1K012708Electrophysiology CatheterAlliance Medical Corp.2002529
+2K052603Reprocessed Daig Livewire Electrophysiology CathetersAlliance Medical Corp.2005026
+2K043392Reprocessed Electrophysiology CathetersAlliance Medical Corp.20050—
+2K030026Reprocessed Electrophysiology CatheterAlliance Medical Corp.20030—
+2K030114Vanguard Reprocessed Diagnostic Electrophysiology CathetersVanguard Medical Concepts, Inc.20030—