510(k) Report

Devices descending from K942231

33 later devices reach Microview II/Microrail II Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K974457Scout 3.2/45 MHZ Coronary Imaging Catheter, Scout 3.2/45 MHZ Coronary Imaging Catheter…Hewlett-Packard Co.199832—
+2K050995Revolution 45 MHZ Rotational Ivus Imaging CatheterVolcano Corporation200531—
+3K172258Novasight Hybrid SystemConavi Medical, Inc.20181Class I
+3K080891Revolution 45MHZ Ivus Imaging CatheterVolcano Corporation20083—
+3K071554Volcano S5/S5I Intravascular Imaging and Pressure SystemVolcano Corporation2008282
+4K252945Novasight Hybrid SystemConavi Medical, Inc.20260—
+4K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipVolcano Corporation201602
+4K122826Preview Forward-Looking Ivus Catheter and Laptop System; Preview Catheter Model 87000…Volcano Corporation20131—
+4K082229S5/S5I Series Intravascular Imaging and Pressure System, Combomap Pressure and Flow SystemVolcano Corporation2008253
+5K132659Volcano Preview Forward-Looking Ivus SystemVolcano Corporation20130—
+5K111706Volcano S5IINTRAVASCULAR Imaging and Pressure SystemVolcano Corporation2011241
+6K123898Volcano S5/S5I Intravascular Ultrasound Imaging and Pressure SystemVolcano Corporation20132110
+6K113486Volcano S5I Intravascular Ultracound Imaging and Pressure SystemVolcano Corporation20122—
+7K133323Volcano Ifr ModalityVolcano Corporation201418—
+7K133142Volcano Lomap,Volcano Lomap Option Kit for Mobile System,Volcano Lomap Option for…Volcano Corporation20130—
+8K183320Ilumien Optis, Optis Integrated, Optis MobileSt. Jude Medical (Now Abbott Medical)20192—
+8K183099QUANTIEN Measurement SystemSt. Jude Medical (Now Abbott Medical)20193—
+8K173860s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound…Volcano Corporation20184—
+8K153369SW v3.5 Install Kit, CORE Mobile, SW v3.5 Install Kit, CORE, SW v3.5 Install Kit, s5izVolcano Corporation20152—
+8K150441Volcano iFR Modality, iFR Scout featureVolcano Corporation20159—
+8K143122Volcano iFR Harvest Software (Offline)Volcano Corporation20150—
+9K252238CoroFlow Cardiovascular SystemCoroventis Research AB20250—
+9K233948Provisio™ SLT IVUS™ SystemProvisio Medical, Inc.20240—
+9K232386ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™…Abbott Medical20230—
+9K220243Ultiri Measurement SystemAbbott Medical20220—
+9K201881CoroFlow Cardiovascular SystemCoroventis Research AB20201—
+9K192267ILUMIEN System with AptiVue Software version D.3Abbott Medical20190—
+9K190078IntraSightVolcano Corporation20192—
+9K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2…Volcano Corporation201701
+9K170133FFR V2.5Philips Volcano201751
+9K170385CORE M2 Vascular SystemVolcano Corporation20171—
+10K253714IntraSight PlusPhilips Image Guided Therapy Corporation202601
+10K203719IntraSight MobileVolcano Corporation202101