510(k) Report

Devices descending from K223666

2 later devices reach Ablacath™ Mapping Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253205OptiMap Catheter - 50mm (OPTI-CATH2-50)Cortex, Inc.20261—
+2K261012OptiMap Catheter - 60mm (OPTI-CATH2-60)Cortex, Inc.20260—