510(k) Report

Devices descending from K240366

4 later devices reach EP•XT™ Unidirectional Steerable Diagnostic Catheter; Dynamic Tip™… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252794Vision-MR™ Diagnostic CatheterImricor Medical Systems, Inc.20261—
+1K252405Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable…Surgical Instrument Service and Savings, Inc.20250—
+1K250772Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable…Surgical Instrument Service and Savings, Inc.20250—
+2K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.20260—