510(k) Report

Devices descending from K190338

3 later devices reach 046 Zenith Flex through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252046Zoom System (Zoom 4S Catheter)Imperative Care, Inc.20250—
+1K241221CEREGLIDE 42 Intermediate Catheter; CEREGLIDE 57 Intermediate Catheter; Cerenovus…Cerenovus, Inc.20241—
+2K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.20260—