510(k) Report

Devices descending from K153443

14 later devices reach ASAHI Astato XS 40 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230377CROSSLEAD Penetration Peripheral Guide WireAsahi Intecc Co., Ltd.20230—
+1K213834Cardio Flow Peripheral Guide WireCardio Flow Inc.,20220—
+1K163426ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ExtensionAsahi Intecc Co., Ltd.201711—
+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—
+2K203529VASSALLO GT HybridFilmecc Co., Ltd.20211—
+2K203533Vassallo GTFilmecc Co., Ltd.20213—
+2K173277ASAHI PTCA Guide Wire ASAHI SION blackAsahi Intecc Co., Ltd.20180—
+3K232574VASSALLO GT Crossing14Filmec Co., Ltd.20230—
+3K232578Vassallo GT 018 G12; Vassallo GT 018 G30Filmec Co., Ltd.20230—
+3K223432Vassallo GT 018 HybridFilmecc Co., Ltd.20230—
+3K213949VASSALLO GT 018 FloppyFilmecc Co., Ltd.20220—