510(k) Report

Devices descending from K041531

79 later devices reach Asahi Ptca Guide Wire Confianza Pro through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171933ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro MicrocatheterAsahi Intecc Co., Ltd.20187—
+1K163426ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ExtensionAsahi Intecc Co., Ltd.201711—
+1K152497PW GuidewiresTatara Vascular, LLC20160—
+1K133865Asahi Gaia First, Second, ThirdAsahi Intecc Co., Ltd.201429—
+1K101986Asahi Ultimatebros 3 Ptca Guide WireAsahi Intecc Co., Ltd.201130—
+1K083727Stingray Guidewire, Stiff, Models M-3003, M-3004, M-3011, M-3012Bridgepoint Medical200912—
+1K082922Freeway and Railrunner GuidewiresLake Region Mfg., Inc.20080—
+1K081187Bridgepoint Medical Entera Percutaneous Coronary and Peripheral Guidewire, Model M-3001Bridgepoint Medical200813—
+1K070945Asahi Ptca Guide WireAsahi Intecc Co., Ltd.200848—
+1K070212CITOP10 Guidewire, 0.014(1.4MM Tip), CITOP6 Guidewire, 0.014(1.0MM Tip), Citop Support…Ovalum, Ltd.20071—
+1K052339Asahi Ptca Guide WireAsahi Intecc Co., Ltd.200560—
+1K043422Asahi Ptca Guide Wire, J Shape SeriesAsahi Intecc Co., Ltd.200550—
+2K243733SION blue PLUSAsahi Intecc Co., Ltd.20250—
+2K241962CrossloopAsahi Intecc Co., Ltd.20250—
+2K241702CROSSLEAD 0.014inchAsahi Intecc Co., Ltd.20250—
+2K241510CROSSLEAD TrackerAsahi Intecc Co., Ltd.20240—
+2K212211Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold…Vascular Solutions, LLC20221—
+2K212167R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewireVascular Solutions, LLC20220—
+2K211898ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20Asahi Intecc Co., Ltd.20210—
+2K203529VASSALLO GT HybridFilmecc Co., Ltd.20211—
+2K203533Vassallo GTFilmecc Co., Ltd.20213—
+2K193322NovaCross CTO MicrocatheterNitiloop, Ltd.20200—
+2K192599ASAHI PTCA Guide Wire ASAHI Gaia NextAsahi Intecc Co., Ltd.20200—
+2K182420ASAHI Corsair Pro XSAsahi Intecc Co., Ltd.20180—
+2K173277ASAHI PTCA Guide Wire ASAHI SION blackAsahi Intecc Co., Ltd.20180—
+2K171897Approach CTO Microwire GuideCook Incorporated201703
+2K153106ASAHI Fielder XT-A, ASAHI Fielder XT-RAsahi Intecc Co., Ltd.201621—
+2K141339Asahi RG3 Guidewire/Asahi RG3 Soft GuidewireAsahi Intecc Co., Ltd.20146—
+2K122795Stingray GuidewiresBridgepoint Medical201201
+2K102725Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000…Bridge Medical, Inc.2011111
+2K110553Asahi Treasure Floppy Peripheral Guide WireAsahi Intecc USA, Inc.201112—
+2K103057Asahi Astato XS 20 Peripheral Guide WireAsahi Intecc Co., Ltd.201021—
+2K100578Asahi Sion Ptca Guide Wire Model AHW14R001S & AHW14R301SAsahi Intecc Co., Ltd.201036—
+2K100710Roll-X GuidewireSt Jude Medical20100—
+2K083904Asahi Suoh Ptca Guide WireAsahi Intecc Co., Ltd.200937—
+2K082304Roll-X GuidewireSt Jude Medical20082—
+2K071721Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Asahi Intecc Co., Ltd.200727—
+2K062186Asahi Ptca Guide Wire, Fielder J, Model AGP140000J, AGP140300JAsahi Intecc Co., Ltd.200649—
+3K232574VASSALLO GT Crossing14Filmec Co., Ltd.20230—
+3K232578Vassallo GT 018 G12; Vassallo GT 018 G30Filmec Co., Ltd.20230—
+3K223432Vassallo GT 018 HybridFilmecc Co., Ltd.20230—
+3K220647GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272)…Vascular Solutions, LLC20220—
+3K213949VASSALLO GT 018 FloppyFilmecc Co., Ltd.20220—
+3K213834Cardio Flow Peripheral Guide WireCardio Flow Inc.,20220—
+3K191464Asahi PTCA Guide Wire Asahi SION SeriesAsahi Intecc Co., Ltd.20191—
+3K180784ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ESAsahi Intecc Co., Ltd.20180—
+3K172315Straub Endovascular SystemStraub Medical AG20182Class I
+3K162842ASAHI PTCA Guide Wire ASAHI SUOH 03Asahi Intecc Co., Ltd.20170—
+3K153443ASAHI Astato XS 40Asahi Intecc Co., Ltd.201614—
+3K152401Stingray LP CatheterBoston Scientific Corporation20151—
+3K151234R350 guidewireVascular Solutions, Inc.20155—
+3K150445ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)Asahi Intecc Co., Ltd.201516—
+3K134031Threader Monorail Micro-Dilatation Catheter, Threader Over-the-Wire Micro-Dilatation…Boston Scientific Corporation20140—
+3K122469Asahi Ptca Guide Wire Asahi Sion 180CMJ Asahi Ptca Guide Wire Asahi Sion 300CMJAsahi Intecc Co., Ltd.201331—
+3K122468Asahi Ptca Guide Wire Asahi Sion Blue 180CM Asahi Ptca Guide Wire Asahi Sion Blue 3300CM…Asahi Intecc Co., Ltd.201316—
+3K120533Bigboss Catheters Mantatay Catheter Mantaray GuidewiresBridgepoint Medical20125—
+3K112381HI Torque Connect GuidewireLake Region Medical20111—
+3K101729Neowire Pta/Ptca GuidewireNeometrics, Inc.20100—
+4K230377CROSSLEAD Penetration Peripheral Guide WireAsahi Intecc Co., Ltd.20230—
+4K231176Stingray LP CatheterBoston Scientific20230—
+4K221163Tunnel Crossing CatheterTractus Vascular, LLC20230—
+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—
+4K211738Rotarex Atherectomy SystemC.R. Bard, Inc.20211Class I
+4K193596Wingman 14, Wingman 14C, Wingman 18, Wingman 35Reflow Medical20201—
+4K190176MinamoAsahi Intecc Co., Ltd.20191—
+4K183357XableCath Crossing CatheterXablecath, Inc.20190—
+4K161702Endura guidewireVascular Solutions, Inc.20164—
+4K140536HI Torque Connect Guidewire, HI Torque Connect Flex Guidewire, HI Torque Connect 250T…Lake Region Medical20140—
+4K121745Mantaray GuidewiresBridgepoint Medical20120—
+5K262013Kiba CTO Crossing CatheterReflow Medical, Inc.20260—
+5K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD…FMD Co., Ltd.20260—
+5K242597CROSSLEAD 0.018inchAsahi Intecc Co., Ltd.20250—
+5K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.20250Class I
+5K240387MINAMO blue; MINAMO violaAsahi Intecc Co., Ltd.20240—
+5K163444Spectre guidewireVascular Solutions, Inc.20173—
+6K180128Warrior 14 guidewireVascular Solutions, Inc.20180—
+6K173532Raider GuidewireVascular Solutions, Inc.20171—
+7K181647Bandit guidewireVascular Solutions, Inc.20180—