510(k) Report

Devices descending from K072012

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

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