510(k) Report

Devices descending from K031662

26 later devices reach Pressure Wire Sensor, Models 12004/12304 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K062769Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB200625—
+2K132474Cardiovascular Pressure Measurement (CPM) System, Navvus CatheterAcist Medical Systems201410—
+2K080813Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB200813—
+3K190473ACIST RXi System and Navvus II CatheterAcist Medical Systems, Inc.20191—
+3K141275Endophys Pressure Sensing Sheath KitEndophys, Inc.20154—
+3K141615Endophys Blood Pressure MonitorEndophys, Inc.20152—
+3K113584Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical20128—
+3K111854AO Usb Receiver, WI-Box, WI-Box Psu Kit, WI-Box Xpress Cable, PW Usb ReceiverSt. Jude Medical Systems AB20110—
+3K111201C7 XR Imaging SystemLightlab Imaging, Inc.20112—
+4K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc.20240—
+4K160945Endophys Blood Pressure MonitorEndophys Holdings, LLC20161—
+4K160272Endophys Pressure Sensing Sheath KitEndophys, Inc.20163—
+4K150237ILUMIEN, Drageonfly OPTIS Imaging CatheterLightlab Imaging, Inc.20151—
+4K131452Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB20137—
+5K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLC20230—
+5K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—
+5K190852Zurich Pressure Guidewire System Model 100Zurich Medical, Inc.20190—
+5K180620Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC20180—
+5K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC20171—
+5K151610Comet Pressure GuidewireBoston Scientific Corporation20151—
+5K140466Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300St. Jude Medical Systems AB20142—
+5K133587Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300St. Jude Medical Systems AB20130—
+6K193279Comet II Pressure GuidewireBoston Scientific Corporation20190—
+6K190098Endophys Pressure Sensing SheathEndophys Holdings, LLC20190—
+6K161171PressureWire X GuidewireSt. Jude Medical, Inc.20161—
+7K180558PressureWire XSt. Jude Medical (Now Part of Abbott Medical)20180—