510(k) Report

Devices descending from K080813

13 later devices reach Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), Receiver through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113584Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical20128—
+1K111854AO Usb Receiver, WI-Box, WI-Box Psu Kit, WI-Box Xpress Cable, PW Usb ReceiverSt. Jude Medical Systems AB20110—
+1K111201C7 XR Imaging SystemLightlab Imaging, Inc.20112—
+2K150237ILUMIEN, Drageonfly OPTIS Imaging CatheterLightlab Imaging, Inc.20151—
+2K131452Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB20137—
+3K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—
+3K190852Zurich Pressure Guidewire System Model 100Zurich Medical, Inc.20190—
+3K151610Comet Pressure GuidewireBoston Scientific Corporation20151—
+3K140466Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300St. Jude Medical Systems AB20142—
+3K133587Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300St. Jude Medical Systems AB20130—
+4K193279Comet II Pressure GuidewireBoston Scientific Corporation20190—
+4K161171PressureWire X GuidewireSt. Jude Medical, Inc.20161—
+5K180558PressureWire XSt. Jude Medical (Now Part of Abbott Medical)20180—