510(k) Report

Devices descending from K050877

16 later devices reach Coronary Sinus Deflectable Mapping Catheter, 4 FR, 5 FR, 6 FR & 7 FR through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K100254Reprocessed CS BI-Diectional Diagnostic Electrophysiology CatheterAscent Healthcare Solutions2010127
+1K090898Coronary Sinus Deflectable Mapping Catheter, Model D-1263-01, Webster CS Catheter with…Biosense Webster, Inc.2009141
+2K181056Reprocessed CS Diagnostic Electrophysiology CatheterStryker Sustainability Solutions20190—
+2K150357Reprocessed Electrophysiology Diagnostic CathetersSterilmed, Inc.20150—
+2K101991Webster Duo-Decapolar CatheterBiosense Webster, Inc.20113—
+2K101345Webster CS Catheter with EZ Steer Technology, Webster CS Catheter with EZ Steer…Biosense Webster, Inc.2010131
+3K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer…Surgical Instrument Service and Savings Inc.(Dba Medline Ren20240Class I
+3K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…Sterilmed, Inc.20240—
+3K233825Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health20240—
+3K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…Biosense Webster, Inc.20233—
+3K203655Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS…Innovative Health, LLC20210—
+3K190980Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterInnovative Health, LLC20191—
+3K170922Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS…Innovative Health, LLC20171—
+3K130602Lasso Nav Duo Loop CatheterBiosense Webster, Inc.201301
+3K121158Reprocessed Electrophysiology Diagnostic CathetersSterilmed, Inc.20120—
+4K233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.20230—