510(k) Report

Devices descending from K934359

34 later devices reach Scimed Strike Steerable Guide Wire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K033742Boston Scientific V-18 Control WireBoston Scientific Corp200433—
+2K112381HI Torque Connect GuidewireLake Region Medical20111—
+2K061984TreasureAsahi Intecc Co., Ltd.200632—
+3K163426ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ExtensionAsahi Intecc Co., Ltd.201711—
+3K140536HI Torque Connect Guidewire, HI Torque Connect Flex Guidewire, HI Torque Connect 250T…Lake Region Medical20140—
+3K110553Asahi Treasure Floppy Peripheral Guide WireAsahi Intecc USA, Inc.201112—
+3K103057Asahi Astato XS 20 Peripheral Guide WireAsahi Intecc Co., Ltd.201021—
+3K083145Asahi Guide Wire Extension, Model AG149000Asahi Intecc Co., Ltd.200914—
+3K083146Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000Asahi Intecc Co., Ltd.200817—
+3K071721Asahi Astato 30 Peripheral Guide Wire, Models - PAGH18M071, PAGH18M371Asahi Intecc Co., Ltd.200727—
+4K243733SION blue PLUSAsahi Intecc Co., Ltd.20250—
+4K241962CrossloopAsahi Intecc Co., Ltd.20250—
+4K241702CROSSLEAD 0.014inchAsahi Intecc Co., Ltd.20250—
+4K241510CROSSLEAD TrackerAsahi Intecc Co., Ltd.20240—
+4K213834Cardio Flow Peripheral Guide WireCardio Flow Inc.,20220—
+4K203529VASSALLO GT HybridFilmecc Co., Ltd.20211—
+4K203533Vassallo GTFilmecc Co., Ltd.20213—
+4K173277ASAHI PTCA Guide Wire ASAHI SION blackAsahi Intecc Co., Ltd.20180—
+4K172315Straub Endovascular SystemStraub Medical AG20182Class I
+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—
+4K101985Asahi Guide Wire Extension 165CMAsahi Intecc Co., Ltd.201113—
+5K232574VASSALLO GT Crossing14Filmec Co., Ltd.20230—
+5K232578Vassallo GT 018 G12; Vassallo GT 018 G30Filmec Co., Ltd.20230—
+5K230377CROSSLEAD Penetration Peripheral Guide WireAsahi Intecc Co., Ltd.20230—
+5K223432Vassallo GT 018 HybridFilmecc Co., Ltd.20230—
+5K222631Vassallo GT ExtFilmecc Co., Ltd.20220—
+5K213868ASAHI Gladius Mongo18 PV ESAsahi Intecc Co., Ltd.20221—
+5K213949VASSALLO GT 018 FloppyFilmecc Co., Ltd.20220—
+5K212268FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXTFMD Co., Ltd.20221—
+5K211738Rotarex Atherectomy SystemC.R. Bard, Inc.20211Class I
+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