510(k) Report

Devices descending from K101991

3 later devices reach Webster Duo-Decapolar Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…Sterilmed, Inc.20240—
+1K233825Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health20240—
+1K190980Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health, LLC20191—