510(k) Report

Devices descending from K081576

3 later devices reach Blazer DX-20 Diagnostic Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230503Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter CableBoston Scientific20230—
+1K211375Blazer™ Dx-20 Bidirectional Steerable Diagnostic CatheterBoston Scientific Corporation20211—
+2K232651BLAZER™ Dx-20 Bidirectional Steerable Diagnostic CatheterBoston Scientific Corporation20230—