510(k) Report

Devices descending from K970466

49 later devices reach Radius Ptca Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K140695Cougar Guidewire, Zinger Guidwire, Thunder Guidewire, Provia Guidewire, Intuition…Medtronic, Inc.20140—
+1K091582GTX Guidewire, Models TBD-GTX 1, 3,6,9,12, 15Medtronic Vascular200910Class I
+1K032899Radius Cougar WireRadius Medical Technologies, Inc.20031Class I
+1K022201Radius Micro SnareRadius Medical Technologies, Inc.200332—
+1K021441Radius SnareRadius Medical Technologies, Inc.200236—
+2K112957HI-Torque PowerturnAbbott Vascular-Cardiac Therapies20117—
+2K100470GTX 12 GidewireMedtronic, Inc.20101Class I
+2K071457Modification to Radius SnareRadius Medical Technologies, Inc.20072—
+2K032426Gunhter Tulip Vena Cava Mreye Filter and Retrieval SetCook, Inc.200331—
+3K163307Expro Elite Snare, Sympro Elite SnareVascular Solutions, Inc.20170—
+3K142415Hi-Torque JET Guide Wire FamilyAbbott Vascular, Inc.20140—
+3K122573HI-Torque Command Guide Wire FamilyAbbott Vascular, Inc.20126—
+3K081410Option Vena Cava FilterRex Medical20096—
+3K080364Findrwirz Guide Wire SystemSentreheart, Inc.20080Class I
+3K073374Cook Clect Vena Cava Filter, Gunther Tulip Vena Cava Filter Retrieval SetWilliam Cook Europe Aps200816—
+3K043509Gunther Tulip Vena Cava Filter SetCook, Inc.20050—
+3K034050Cordis Optease Vena Cava Filter, Models 466-F220A and 466-F220B; Retrievable Catheter…Cordis Corporation20045Class I
+4K240997Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20241—
+4K191502Heraeus Peripheral GuidewireHeraeus Medical Components, LLC20190—
+4K181757Günther Tulip® Vena Cava Filter Retrieval SetCook Incorporated20181—
+4K172073Hi-Torque Command 18 Guide WireAbbott Vascular20170—
+4K162875Sentry IVC filterNovate Medical, Ltd.20172—
+4K160747Angel CatheterBio2 Medical, Inc.20160—
+4K152560Bard Snare Retrieval KitNeometrics, Inc.20152—
+4K152404Hi-Torque Command 18 Guide WireAbbott Vascular20151—
+4K140286Optease Vena Cava Filter and Optease Retrieval CathteterCordis, A Johnson & Johnson Co.20140—
+4K133681Crux Snare Filter Retrieval SetVolcano Corporation20141—
+4K133243Option Elite Vena Cava Filter SystemRex Medical, L.P.201322
+4K120402Crux Vena Cava Filter SystemCrux Biomedical20122—
+4K121629Cook Celect Platinum Vena Cava Filter Set for Femoral Approach Cook Celect Platium Vena…William Cook Europe Aps20120—
+4K112185Foursnare Vascular Retrieval SnareCook, Inc.20116Class I
+4K091077Optease Vena Cava Filter and Retrieval CatheterCordis Corp., A Johnson & Johnson Co.20101Class I
+5K250552Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide WireAbbott Medical20250—
+5K242612Option ELITE Vena Cava Filter System (352506070E 352506100E)Argon Medical Devices, Inc.20240—
+5K222254Gunther Tulip Vena Cava Filter Retrieval SetCook Incorporated20230—
+5K222083LimFlow V-CeiverLimFlow, Inc.20221—
+5K213494Aveir Retrieval CatheterAbbott Medical20220—
+5K191758Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc.20191—
+5K173236Sentry IVC FilterNovate Medical, Ltd.20181—
+5K170987Captus Vascular Retrieval SystemAvantec Vascular Corporation20171—
+5K160593Indy OTW Vascular RetrieverCook Incorporated20160—
+5K152136Recovery Cone Removal SystemC.R. Bard, Inc.20160—
+5K143405Option (TM) ELITE Vena Cava Filter 100cm SystemRex Medical, L.P.20151—
+5K122585Crux Vena Cava Filter SystemCrux Biomedical20131—
+6K242776LimFlow V-CeiverLimFlow, Inc.20250—
+6K232443Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval KitArgon Medical Devices, Inc.20230—
+6K212988ONO Retrieval DeviceOnocor Vascular, LLC20220—
+6K181202Sentry IVC FilterNovate Medical, Ltd.20180—
+6K150262Crux Vena Cava Filter System, femoral; Crux Vena Cava Filter System, jugularVolcano Corporation20150—