510(k) Report

Devices descending from K940168

11 later devices reach Diagnostic II Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081576Blazer DX-20 Diagnostic CatheterBoston Scientific Corp20093—
+1K051043Vanguard Reprocessed Diagnostic Electrophysiology CathetersVanguard Medical Concepts, Inc.20050—
+1K012708Electrophysiology CatheterAlliance Medical Corp.2002529
+2K230503Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter CableBoston Scientific20230—
+2K211375Blazer™ Dx-20 Bidirectional Steerable Diagnostic CatheterBoston Scientific Corporation20211—
+2K052414Reprocessed Electrophysiology CatheterAlliance Medical Corp.20050—
+2K052603Reprocessed Daig Livewire Electrophysiology CathetersAlliance Medical Corp.2005026
+2K043392Reprocessed Electrophysiology CathetersAlliance Medical Corp.20050—
+2K043393Reprocessed EP Technologies Electrophysiology CathetersAlliance Medical Corp.20051—
+2K030026Reprocessed Electrophysiology CatheterAlliance Medical Corp.20030—
+3K232651BLAZER™ Dx-20 Bidirectional Steerable Diagnostic CatheterBoston Scientific Corporation20230—