510(k) Report

Devices descending from K140466

2 later devices reach Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161171PressureWire X GuidewireSt. Jude Medical, Inc.20161—
+2K180558PressureWire XSt. Jude Medical (Now Part of Abbott Medical)20180—