510(k) Report

Devices descending from K131452

7 later devices reach Pressurewire; Certus, Certus 300, Aeris, Aeris 300 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K190852Zurich Pressure Guidewire System Model 100Zurich Medical, Inc.20190—
+1K151610Comet Pressure GuidewireBoston Scientific Corporation20151—
+1K140466Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300St. Jude Medical Systems AB20142—
+1K133587Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300St. Jude Medical Systems AB20130—
+2K193279Comet II Pressure GuidewireBoston Scientific Corporation20190—
+2K161171PressureWire X GuidewireSt. Jude Medical, Inc.20161—
+3K180558PressureWire XSt. Jude Medical (Now Part of Abbott Medical)20180—