510(k) Report

Devices descending from K033742

33 later devices reach Boston Scientific V-18 Control Wire through their predicates, nearest generation first.

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