510(k) Report

Devices descending from K981381

190 later devices reach Acs HI-Torque Cross-IT Guide Wire with Hydrocoat Hydrophilic Coating Product… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K011986Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc.200276—
+1K990639Acs HI-Torque Cross IT 100XT, 200XT and 300XT Guide Wires with Hydrocoat Hydrophilic…Guidant Corp.1999189—
+2K080901Lbi Embolectomy SystemLumen Biomedical, Inc.20086—
+2K071721Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Asahi Intecc Co., Ltd.200727—
+2K063819Asahi Ptca Guide Wire, Fielder FCAsahi Intecc Co., Ltd.200751—
+2K062186Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd.200649—
+2K051062VP Wire GW140ST (.014 165CM, Standar), Model GW140ST; VP Wire GW140SO (.014 165CM, Soft)…Flowcardia, Inc.20050—
+2K022762Jowire Neo's Ptca Catheter Guidewires, Models AG141000, AG142000, AG143000, AG141002…Jomed, Inc.2002104—
+2K021323Modification to Safe-Steer Guide Wire SystemIntra Luminal Therapeutics, Inc.200275—
+3K241962CrossloopAsahi Intecc Co., Ltd.20250—
+3K172315Straub Endovascular SystemStraub Medical AG20182Class I
+3K171933ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro MicrocatheterAsahi Intecc Co., Ltd.20187—
+3K163426ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ExtensionAsahi Intecc Co., Ltd.201711—
+3K153106ASAHI Fielder XT-A, ASAHI Fielder XT-RAsahi Intecc Co., Ltd.201621—
+3K153443ASAHI Astato XS 40Asahi Intecc Co., Ltd.201614—
+3K150445ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)Asahi Intecc Co., Ltd.201516—
+3K141751Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular Guide Wire Asahi…Asahi Intecc Co., Ltd.20154—
+3K122468Asahi Ptca Guide Wire Asahi Sion Blue 180CM Asahi Ptca Guide Wire Asahi Sion Blue 3300CM…Asahi Intecc Co., Ltd.201316—
+3K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC20125—
+3K113716Asahi Chikai V Peripheral Vascular Guide WireAsahi Intecc Co., Ltd.20121—
+3K112979Asahi Chikai 10 Neurovascular Guide WireAsahi Intecc Co., Ltd.20116—
+3K112381HI Torque Connect GuidewireLake Region Medical20111—
+3K101986Asahi Ultimatebros 3 Ptca Guide WireAsahi Intecc Co., Ltd.201130—
+3K110584Asahi Chikai Neurovascular Guide WireAsahi Intecc Co., Ltd.201111—
+3K110553Asahi Treasure Floppy Peripheral Guide WireAsahi Intecc USA, Inc.201112—
+3K103057Asahi Astato XS 20 Peripheral Guide WireAsahi Intecc Co., Ltd.201021—
+3K100578Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301SAsahi Intecc Co., Ltd.201036—
+3K083904Asahi Suoh Ptca Guide WireAsahi Intecc Co., Ltd.200937—
+3K083145Asahi Guide Wire Extension, Model AG149000Asahi Intecc Co., Ltd.200914—
+3K070945Asahi Ptca Guide WireAsahi Intecc Co., Ltd.200848—
+3K072705Asahi Ptca Guide Wire, Fielder FC J, Models: AGP140001J, AGP140301JAsahi Intecc Co., Ltd.200722—
+3K072431Asahi Ptca Guide Wire, X-TremeAsahi Intecc Co., Ltd.200722—
+3K061984TreasureAsahi Intecc Co., Ltd.200632—
+3K052339Asahi Ptca Guide WireAsahi Intecc Co., Ltd.200560—
+3K052022Asahi Ptca Guide Wire FielderAsahi Intecc Co., Ltd.200559—
+3K043422Asahi Ptca Guide Wire, J Shape SeriesAsahi Intecc Co., Ltd.200550—
+3K041531Asahi Ptca Guide Wire Confianza ProAsahi Intecc Co., Ltd.200479—
+3K032031Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.200436—
+3K031842Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.200340—
+3K032615Asahi Ptca Catheter Guide Wires, Models AGH147000 and AGH147300Asahi Intecc Co., Ltd.200352—
+3K031277Jowire Asahi Ptca Catheter Guide Wires, Models…Jomed, Inc.200392—
+4K243383CHIKAI Nexus 014Asahi Intecc Co., Ltd.20250—
+4K243733SION blue PLUSAsahi Intecc Co., Ltd.20250—
+4K241702CROSSLEAD 0.014inchAsahi Intecc Co., Ltd.20250—
+4K240871Synxess Neurovascular GuidewireEnlight Medical Technologies (Shenzhen) Co., Ltd.20240—
+4K241510CROSSLEAD TrackerAsahi Intecc Co., Ltd.20240—
+4K230377CROSSLEAD Penetration Peripheral Guide WireAsahi Intecc Co., Ltd.20230—
+4K220780ROVO Mechanical Thrombectomy Device2mg, Inc.20231—
+4K213868ASAHI Gladius Mongo18 PV ESAsahi Intecc Co., Ltd.20221—
+4K212268FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXTFMD Co., Ltd.20221—
+4K213834Cardio Flow Peripheral Guide WireCardio Flow Inc.,20220—
+4K212211Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold…Vascular Solutions, LLC20221—
+4K212167R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewireVascular Solutions, LLC20220—
+4K211898ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20Asahi Intecc Co., Ltd.20210—
+4K211738Rotarex Atherectomy SystemC.R. Bard, Inc.20211Class I
+4K203529VASSALLO GT HybridFilmecc Co., Ltd.20211—
+4K203533Vassallo GTFilmecc Co., Ltd.20213—
+4K200629Aspire Mechanical Aspirator GControl Medical Technology20200—
+4K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorControl Medical Technology20201—
+4K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+4K192599ASAHI PTCA Guide Wire ASAHI Gaia NextAsahi Intecc Co., Ltd.20200—
+4K191464Asahi PTCA Guide Wire Asahi SION SeriesAsahi Intecc Co., Ltd.20191—
+4K190176MinamoAsahi Intecc Co., Ltd.20191—
+4K191714ASAHI Neurovascular Guide Wire CHIKAI X 014 softAsahi Intecc Co., Ltd.20190—
+4K183070ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010Asahi Intecc Co., Ltd.20190—
+4K182420ASAHI Corsair Pro XSAsahi Intecc Co., Ltd.20180—
+4K180784ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ESAsahi Intecc Co., Ltd.20180—
+4K173277ASAHI PTCA Guide Wire ASAHI SION blackAsahi Intecc Co., Ltd.20180—
+4K171613ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tipAsahi Intecc Co., Ltd.20170—
+4K162842ASAHI PTCA Guide Wire ASAHI SUOH 03Asahi Intecc Co., Ltd.20170—
+4K161912ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tipAsahi Intecc Co., Ltd.20160—
+4K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd.20160—
+4K160659ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)Asahi Intecc Co., Ltd.20160—
+4K152497PW GuidewiresTatara Vascular, LLC20160—
+4K140536HI Torque Connect Guidewire, HI Torque Connect Flex Guidewire, HI Torque Connect 250T…Lake Region Medical20140—
+4K141339Asahi RG3 Guidewire/Asahi RG3 Soft GuidewireAsahi Intecc Co., Ltd.20146—
+4K133865Asahi Gaia First, Second, ThirdAsahi Intecc Co., Ltd.201429—
+4K122469Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJAsahi Intecc Co., Ltd.201331—
+4K101985Asahi Guide Wire Extension 165CMAsahi Intecc Co., Ltd.201113—
+4K100710Roll-X GuidewireSt Jude Medical20100—
+4K083727Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012Bridgepoint Medical200912—
+4K082922Freeway and Railrunner GuidewiresLake Region Mfg., Inc.20080—
+4K083146Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000Asahi Intecc Co., Ltd.200817—
+4K081187Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001Bridgepoint Medical200813—
+4K082304Roll-X GuidewireSt Jude Medical20082—
+4K070212CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support…Ovalum, Ltd.20071—
+4K062868The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02Flowcardia, Inc.200731—
+4K051670RF Tunneler WireBaylis Medical Co., Inc.20066—
+4K040067Clirpath Excimer Laser CatheterSpectranetics Corp.200436—
+4K040037Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.200418—
+4K033708Modification to Safe-Cross Radio Frequency Total Occlusion Crossing SystemIntra Luminal Therapeutics, Inc.20032—
+5K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD…FMD Co., Ltd.20260—
+5K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.20260—
+5K250013VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S…Control Medical Technology, Inc. / Dba Ventiv Scientific20250—
+5K242597CROSSLEAD 0.018inchAsahi Intecc Co., Ltd.20250—
+5K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.20250Class I
+5K240387MINAMO blue; MINAMO violaAsahi Intecc Co., Ltd.20240—
+5K232574VASSALLO GT Crossing14Filmec Co., Ltd.20230—
+5K232578Vassallo GT 018 G12; Vassallo GT 018 G30Filmec Co., Ltd.20230—
+5K223432Vassallo GT 018 HybridFilmecc Co., Ltd.20230—