510(k) Report

Devices descending from K080425

7 later devices reach CS Refstar Catheter (D- and F-Curves), Models D-1285-01 and D-1285-02 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…Sterilmed, Inc.20240—
+1K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…Biosense Webster, Inc.20233—
+1K180710Reprocessed DecaNav Diagnostic Electrophysiology CatheterInnovative Health, LLC20180—
+1K091780Guided Measurement Catheter (GMC)Mediguide, Ltd.20091—
+2K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer…Surgical Instrument Service and Savings Inc.(Dba Medline Ren20240Class I
+2K233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.20230—
+2K142235CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner CatheterSt Jude Medical20140—