510(k) Report

Devices descending from K201750

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)Medtronic20240—
+1K231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS…Biosense Webster, Inc.20233—
+2K241224Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer…Surgical Instrument Service and Savings Inc.(Dba Medline Ren20240Class I
+2K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…Sterilmed, Inc.20240—
+2K233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.20230—