510(k) Report

Devices descending from K062251

5 later devices reach Reflexion Spiral Variable Radius Catheter, Model 402804 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090323Reprocessed Electrophysiology CathetersAscent Healthcare Solutions20090—
+1K072012Reflexion Spiral Variable Radius CatheterSt Jude Medical20074—
+2K191170Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology CatheterInnovative Health, LLC20190—
+2K080179Reflexion HD High-Density Mapping CatheterSt Jude Medical200911
+3K101623Inquiry Afocusii Diagnostic CatheterSt Jude Medical20100—