510(k) Report

Devices descending from K123837

11 later devices reach Pentaray Nav Eco High-Density Mapping Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K201806Reprocessed PentaRay Nav eco High-Density Mapping CatheterSterilmed Inc. (Johnson and Johnson)20210—
+1K201750Pentaray Nav eco High-Density Mapping CatheterBiosense Webster, Inc.20205—
+1K193237Carto Octaray Mapping Catheter with Trueref TechnologyBiosense Webster, Inc.20202—
+1K190785Reprocessed PentaRay Nav eco High-Density Mapping CatheterInnovative Health, LLC20190—
+2K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)Medtronic20240—
+2K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…Biosense Webster, Inc.20233—
+2K211438OPTRELL Mapping Catheter with TRUEref TechnologyBiosense Webster, Inc.20221—
+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—
+3K233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.20230—
+3K230253OPTRELL™ Mapping Catheter with TRUEref™ TechnologyBiosense Webster, Inc.20230—