510(k) Report

Devices descending from K060341

43 later devices reach Sherlock Tip Location System (TLS) through their predicates, nearest generation first.

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