510(k) Report

Devices descending from K935380

45 later devices reach Vascular Access Catheter Accessories through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K060341Sherlock Tip Location System (TLS)C.R. Bard, Inc.200643—
+1K9730571.4 FR Mapcath Sensor StyletNavion Biomedical Corp.19970—
+2K063240Sherlock TLS Stylet, Sherlock TLS DetectorC.R. Bard, Inc.20064218
+3K091324Sherlock 3CG Tip Positioning System, Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc.20093811
+3K081626Flowpicc ConsoleVasonova, Inc.200839—
+3K081625Flowpicc StyletVasonova, Inc.200840—
+4K172397Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc.20170—
+4K142267Sherlock 3CG Tip Positioning System StyletC.R. Bard, Inc.20141—
+4K113808The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc.20126—
+4K103255Vascular Positioning System TM (VPS TM System) StyletVasonova, Inc.2011104
+4K103260Vascular Positioning System (VPS System) ConsoleVasonova, Inc.20111—
+4K093510Lumenvu Catheter Guidance SystemSonosite,Inc.20100—
+4K093775Evguide Tip Location SystemRomedex International Srl201034—
+5K222232Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock AssemblyBard Access Systems, Inc.20220—
+5K142889Celerity PICC Tip Confirmation SystemAngioDynamics, Inc.201581
+5K141634Nautilus DeltaRomedex International Srl20154—
+5K141618Arrow VPS Stylet Plus and CG+ Arrow Picc Powered by Arrow VPS Stylet PlusArrow International, Inc (Subsidiary of Teleflex I20141—
+5K140799Celerity SysyemMedcomp (Medical Components, Inc.)2014131
+5K140345The Sherlock 3CG Tip Confirmation System (TCS)C.R. Bard, Inc.20142—
+5K132133CG+ Arrow Jacc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20133Class I
+5K123813Vascular Positioning System (VPS) G4 ConsoleVasonova, Inc.201301
+5K123759CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc. (Subsidiary of Teleflex20133—
+5K122545CG+ Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)20122Class I
+5K121941Arrow Picc Powered by Arrow VPS StyletArrow International (Subsidiary of Teleflex Inc.)2012010
+5K112744Sapiens Tip Confirmation SystemC.R. Bard, Inc.20117—
+6K241910Neonav ECG Tip Location SystemNavi Medical Technologies20252—
+6K200037Piccolo Medical SmartPICC SystemPiccolo Medical, Inc.20213—
+6K180560Sherlock 3CG+ T ip Confirmation SystemC.R. Bard, Inc.20181—
+6K171931Celerity ECG Cable Accessory PackMedcomp (Medical Components, Inc.)20170—
+6K153487CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUSArrow International, Inc. (Subsidiary of Teleflex, Inc.)20160Class I
+6K153423CG+ Arrow JACC powered by Arrow VPS Stylet, CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex, Inc.)20161Class I
+6K152261PICC Tip Positioning AidNostix, LLC20155—
+6K150109Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain…Arrow International (A Subsidiary of Teleflex, Inc.)20150—
+6K143238C3 WaveMedcomp ( Medical Components)20153—
+6K130876CG+ Arrow Picc Powered by Arrow VPS StyletArrow International, Inc.20132Class I
+7K260929Neonav ECG Tip Location SystemNavi Medical Technologies20260—
+7K252792PM2™ System with ECGuide™ ConnectorPiccolo Medical, Inc.20250—
+7K243484PM2+ System and SmartPICC StyletPiccolo Medical, Inc.20250—
+7K240486PM2 System and ECGuide ConnectorPiccolo Medical, Inc.20242—
+7K170934C3 Wave SystemMedical Components, Inc (Dba Medcomp_201721
+7K160925VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.)20164Class I
+7K161765CG+ Arrow JACCArrow International, Inc. (Subsidiary of Teleflex20160—
+8K241587pilot TLSVygon Corporation20250—
+8K220363VPS Rhythm DLX Device with TipTracker TechnologyArrow International, LLC (A subsidiary of Teleflex, Inc.)20220—
+8K180567C3 Wave SystemMedical Components, Inc. (dba MedComp)20180—