510(k) Report

Devices descending from K003452

9 later devices reach Polaris X Catheters, Model 7000D,7001D,7003D,7004D,7005D,7006D through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K211494Polaris X Unidirectional Steerable Diagnostic CatheterBoston Scientific Corporation20211—
+1K160303Reprocessed Polaris X Steerable Diagnostic EP CatheterInnovative Health, LLC20160—
+1K052414Reprocessed Electrophysiology CatheterAlliance Medical Corp.20050—
+1K043393Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp.20051—
+1K012708Electrophysiology CatheterAlliance Medical Corp.2002529
+2K233207Polaris X™ Unidirectional Steerable Diagnostic CatheterBoston Scientific Corporation20230—
+2K052603Reprocessed Daig Livewire Electrophysiology CathetersAlliance Medical Corp.2005026
+2K043392Reprocessed Electrophysiology CathetersAlliance Medical Corp.20050—
+2K030026Reprocessed Electrophysiology CatheterAlliance Medical Corp.20030—