510(k) Report

Devices descending from K101345

13 later devices reach Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer…Surgical Instrument Service and Savings Inc.(Dba Medline Ren20240Class I
+1K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…Biosense Webster, Inc.20233—
+1K203655Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS…Innovative Health, LLC20210—
+1K181056Reprocessed CS Diagnostic Electrophysiology CatheterStryker Sustainability Solutions20190—
+1K170922Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS…Innovative Health, LLC20171—
+1K150357Reprocessed Electrophysiology Diagnostic CathetersSterilmed, Inc.20150—
+1K130602Lasso Nav Duo Loop CatheterBiosense Webster, Inc.201301
+1K121158Reprocessed Electrophysiology Diagnostic CathetersSterilmed, Inc.20120—
+1K101991Webster Duo-Decapolar CatheterBiosense Webster, Inc.20113—
+2K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…Sterilmed, Inc.20240—
+2K233825Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health20240—
+2K233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.20230—
+2K190980Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health, LLC20191—