510(k) Report

Devices descending from K062769

25 later devices reach Pressurewire Certus, Models 12006 and 12306 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132474Cardiovascular Pressure Measurement (CPM) System, Navvus CatheterAcist Medical Systems201410—
+1K080813Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB200813—
+2K190473ACIST RXi System and Navvus II CatheterAcist Medical Systems, Inc.20191—
+2K141275Endophys Pressure Sensing Sheath KitEndophys, Inc.20154—
+2K141615Endophys Blood Pressure MonitorEndophys, Inc.20152—
+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—
+3K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc.20240—
+3K160945Endophys Blood Pressure MonitorEndophys Holdings, LLC20161—
+3K160272Endophys Pressure Sensing Sheath KitEndophys, Inc.20163—
+3K150237ILUMIEN, Drageonfly OPTIS Imaging CatheterLightlab Imaging, Inc.20151—
+3K131452Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB20137—
+4K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLC20230—
+4K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—
+4K190852Zurich Pressure Guidewire System Model 100Zurich Medical, Inc.20190—
+4K180620Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC20180—
+4K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC20171—
+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—
+5K190098Endophys Pressure Sensing SheathEndophys Holdings, LLC20190—
+5K161171PressureWire X GuidewireSt. Jude Medical, Inc.20161—
+6K180558PressureWire XSt. Jude Medical (Now Part of Abbott Medical)20180—