510(k) Report

Devices descending from K031692

30 later devices reach Safe-Cross Deflecting Catheter, Model C114ND1 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K081545One Series Ultra Cartridge, Model 1VIPR30Advanced Medical Optics, Inc.20081—
+1K032784Ilt Safe-Cross Deflecting Catheter, Model C114ND1Intra Luminal Therapeutics, Inc.200327—
+2K143434One Series ULTRA Cartridge, The UNFOLDER Platinum 1 SeriesAbbott Medical Optics, Inc.20150—
+2K040481Safe-Cross Deflecting Catheter, Model C118ND1Intra Luminal Therapeutics, Inc.200426—
+3K062769Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB200625—
+4K132474Cardiovascular Pressure Measurement (CPM) System, Navvus CatheterAcist Medical Systems201410—
+4K080813Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB200813—
+5K190473ACIST RXi System and Navvus II CatheterAcist Medical Systems, Inc.20191—
+5K141275Endophys Pressure Sensing Sheath KitEndophys, Inc.20154—
+5K141615Endophys Blood Pressure MonitorEndophys, Inc.20152—
+5K113584Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical20128—
+5K111854AO Usb Receiver, WI-Box, WI-Box Psu Kit, WI-Box Xpress Cable, PW Usb ReceiverSt. Jude Medical Systems AB20110—
+5K111201C7 XR Imaging SystemLightlab Imaging, Inc.20112—
+6K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc.20240—
+6K160945Endophys Blood Pressure MonitorEndophys Holdings, LLC20161—
+6K160272Endophys Pressure Sensing Sheath KitEndophys, Inc.20163—
+6K150237ILUMIEN, Drageonfly OPTIS Imaging CatheterLightlab Imaging, Inc.20151—
+6K131452Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB20137—
+7K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLC20230—
+7K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—
+7K190852Zurich Pressure Guidewire System Model 100Zurich Medical, Inc.20190—
+7K180620Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC20180—
+7K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC20171—
+7K151610Comet Pressure GuidewireBoston Scientific Corporation20151—
+7K140466Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300St. Jude Medical Systems AB20142—
+7K133587Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300St. Jude Medical Systems AB20130—
+8K193279Comet II Pressure GuidewireBoston Scientific Corporation20190—
+8K190098Endophys Pressure Sensing SheathEndophys Holdings, LLC20190—
+8K161171PressureWire X GuidewireSt. Jude Medical, Inc.20161—
+9K180558PressureWire XSt. Jude Medical (Now Part of Abbott Medical)20180—