510(k) Report

Devices descending from K012947

48 later devices reach Smartflow through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K020127Smartflow Pulse Transmission CoefficientFlorence Medical, Ltd.200247—
+2K022188Radianalyzer, Model 12710Radi Medical Systems AB200246—
+3K042628Modification to: Radianalyzer, Model 12711Radi Medical Systems AB200526—
+3K031662Pressure Wire Sensor, Models 12004/12304Radi Medical Systems AB200326—
+4K092105Radianalyzer XpressRadi Medical Systems AB200925—
+4K062769Pressurewire Certus, Models 12006 and 12306Radi Medical Systems AB200625—
+5K252238CoroFlow Cardiovascular SystemCoroventis Research AB20250—
+5K201881CoroFlow Cardiovascular SystemCoroventis Research AB20201—
+5K190852Zurich Pressure Guidewire System Model 100Zurich Medical, Inc.20190—
+5K151613iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation201510—
+5K141615Endophys Blood Pressure MonitorEndophys, Inc.20152—
+5K132474Cardiovascular Pressure Measurement (CPM) System, Navvus CatheterAcist Medical Systems201410—
+5K123984Quantien Measurement SystemRadi Medical Systems AB20135—
+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—
+5K080813Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverRadi Medical Systems AB200813—
+6K190473ACIST RXi System and Navvus II CatheterAcist Medical Systems, Inc.20191—
+6K191008iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation201981
+6K172182QUANTIEN Measurement SystemSt. Jude Medical (Now Part of the Abbott Medical)20174—
+6K170204FFR Link, FFR Signal Processing ModuleBoston Scientific Corporation201701
+6K160945Endophys Blood Pressure MonitorEndophys Holdings, LLC20161—
+6K150237ILUMIEN, Drageonfly OPTIS Imaging CatheterLightlab Imaging, Inc.20151—
+6K141275Endophys Pressure Sensing Sheath KitEndophys, Inc.20154—
+6K113584Pressurewire Certus, Certus 300, Aeris, Aeris 300, and ReceiverSt Jude Medical20128—
+7K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc.20240—
+7K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLC20230—
+7K223812Sensis Vibe (VD15)Siemens Medical Solutions USA, Inc.202303
+7K201178iLab Polaris Multi-Modality Guidance SystemBoston Scientific20206—
+7K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—
+7K183099QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical)20193—
+7K160272Endophys Pressure Sensing Sheath KitEndophys, Inc.20163—
+7K131452Pressurewire; Certus, Certus 300, Aeris, Aeris 300St. Jude Medical Systems AB20137—
+8K220243Ultiri Measurement SystemAbbott Medical20220—
+8K210889iLab Polaris Multi-Modality Guidance SystemBoston Scientific Corporation20214—
+8K201713AVVIGO Guidance SystemBoston Scientific Corporation20204—
+8K180620Endophys Pressure Sensing Sheath KitEndophys Holdings, LLC20180—
+8K173399Endophys Pressure Sensing Sheath Kit- 8FEndophys Holdings, LLC20171—
+8K151610Comet Pressure GuidewireBoston Scientific Corporation20151—
+8K140466Pressurewire: Aeris Agile Tip, Aeris Agile Tip 300, Certus Agile Tip, Certus Agile Tip 300St. Jude Medical Systems AB20142—
+8K133587Pressurewire Aeris Agile Tip; Pressurewire Aeris Agile Tip 300St. Jude Medical Systems AB20130—
+9K212490AVVIGO Guidance System IIBoston Scientific Corporation20213—
+9K193279Comet II Pressure GuidewireBoston Scientific Corporation20190—
+9K190098Endophys Pressure Sensing SheathEndophys Holdings, LLC20190—
+9K161171PressureWire X GuidewireSt. Jude Medical, Inc.20161—
+10K230884AVVIGO'+ Multi-Modality Guidance SystemBoston Scientific Corporation2023122
+10K221340iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console…Boston Scientific Corporation20230—
+10K180558PressureWire XSt. Jude Medical (Now Part of Abbott Medical)20180—
+11K253692AVVIGO™+ Multi-Modality Guidance SystemBoston Scientific20260—