510(k) Report

Devices descending from K091385

4 later devices reach Approach Hydro ST Wire Guide, Model HMW through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250203SureAx-Guide™Sureax Medical, LLC20250—
+1K110009Roadrunner Uniglide Hydrophilic Wire GuideCook, Inc.20112Class I
+2K130766Roadrunner Uniglide Hydrophilic Wire GuideCook, Inc.20130Class I
+2K123707Alight 16 Superselective Microwire GuideCook, Inc.20130—