510(k) Report

Devices descending from K231312

3 later devices reach PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter… 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
+1K240826Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…Sterilmed, Inc.20240—
+1K233397Cosine-10TM Diagnostic CatheterMedtronic, Inc.20230—