510(k) Report

Devices descending from K942066

40 later devices reach Acs HI-Torque Extra S'port Guide Wire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K972290Acs HI-Torque Ruler Guide WireGuidant Corp.19970—
+1K972142Acs HI-Torque All Star 0.014 Guide Wire with Microglide CoatingGuidant Corp.19970—
+1K963702Acs HI-Torque Iron Man Guide WireAdvanced Cardiovascular Systems, Inc.199736—
+1K961107B. Braun GuidewiresB.Braun Medical, Inc.19960—
+2K982876HI-Torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281, 1003282Guidant Corp.199834—
+2K980294Acs HI-Torque Super Sport Guide Wire with Hydrocoat Hydrophilic CoatingGuidant Corp.19980—
+3K200144HI-TORQUE Steelcore Bare Guide WireAbbott Vascular20200—
+3K071721Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Asahi Intecc Co., Ltd.200727—
+3K061984TreasureAsahi Intecc Co., Ltd.200632—
+4K241962CrossloopAsahi Intecc Co., Ltd.20250—
+4K172315Straub Endovascular SystemStraub Medical AG20182Class I
+4K163426ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ExtensionAsahi Intecc Co., Ltd.201711—
+4K153443ASAHI Astato XS 40Asahi Intecc Co., Ltd.201614—
+4K150445ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)Asahi Intecc Co., Ltd.201516—
+4K112381HI Torque Connect GuidewireLake Region Medical20111—
+4K110553Asahi Treasure Floppy Peripheral Guide WireAsahi Intecc USA, Inc.201112—
+4K103057Asahi Astato XS 20 Peripheral Guide WireAsahi Intecc Co., Ltd.201021—
+4K083145Asahi Guide Wire Extension, Model AG149000Asahi Intecc Co., Ltd.200914—
+4K083146Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000Asahi Intecc Co., Ltd.200817—
+5K243733SION blue PLUSAsahi Intecc Co., Ltd.20250—
+5K241702CROSSLEAD 0.014inchAsahi Intecc Co., Ltd.20250—
+5K241510CROSSLEAD TrackerAsahi Intecc Co., Ltd.20240—
+5K230377CROSSLEAD Penetration Peripheral Guide WireAsahi Intecc Co., Ltd.20230—
+5K213868ASAHI Gladius Mongo18 PV ESAsahi Intecc Co., Ltd.20221—
+5K212268FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXTFMD Co., Ltd.20221—
+5K213834Cardio Flow Peripheral Guide WireCardio Flow Inc.,20220—
+5K211738Rotarex Atherectomy SystemC.R. Bard, Inc.20211Class I
+5K203529VASSALLO GT HybridFilmecc Co., Ltd.20211—
+5K203533Vassallo GTFilmecc Co., Ltd.20213—
+5K173277ASAHI PTCA Guide Wire ASAHI SION blackAsahi Intecc Co., Ltd.20180—
+5K140536HI Torque Connect Guidewire, HI Torque Connect Flex Guidewire, HI Torque Connect 250T…Lake Region Medical20140—
+5K101985Asahi Guide Wire Extension 165CMAsahi Intecc Co., Ltd.201113—
+6K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD…FMD Co., Ltd.20260—
+6K242597CROSSLEAD 0.018inchAsahi Intecc Co., Ltd.20250—
+6K242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.20250Class I
+6K232574VASSALLO GT Crossing14Filmec Co., Ltd.20230—
+6K232578Vassallo GT 018 G12; Vassallo GT 018 G30Filmec Co., Ltd.20230—
+6K223432Vassallo GT 018 HybridFilmecc Co., Ltd.20230—
+6K222631Vassallo GT ExtFilmecc Co., Ltd.20220—
+6K213949VASSALLO GT 018 FloppyFilmecc Co., Ltd.20220—