510(k) Report

Devices descending from K972793

15 later devices reach Pressure Wire Sensor .014, Pressure Wire Interface 10, Pressure Wire Monitor… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K080813Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB200813—
+1K983506Pressurewire Sensor, Model #12001Radi Medical Systems AB19990—
+2K113584Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical20128—
+2K111854AO Usb Receiver, WI-Box, WI-Box Psu Kit, WI-Box Xpress Cable, PW Usb ReceiverSt. Jude Medical Systems AB20110—
+2K111201C7 XR Imaging SystemLightlab Imaging, Inc.20112—
+3K150237ILUMIEN, Drageonfly OPTIS Imaging CatheterLightlab Imaging, Inc.20151—
+3K131452Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB20137—
+4K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—
+4K190852Zurich Pressure Guidewire System Model 100Zurich Medical, Inc.20190—
+4K151610Comet Pressure GuidewireBoston Scientific Corporation20151—
+4K140466Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300St. Jude Medical Systems AB20142—
+4K133587Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300St. Jude Medical Systems AB20130—
+5K193279Comet II Pressure GuidewireBoston Scientific Corporation20190—
+5K161171PressureWire X GuidewireSt. Jude Medical, Inc.20161—
+6K180558PressureWire XSt. Jude Medical (Now Part of Abbott Medical)20180—