510(k) Report

Devices descending from K163426

11 later devices reach ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K243733SION blue PLUSAsahi Intecc Co., Ltd.20250—
+1K241962CrossloopAsahi Intecc Co., Ltd.20250—
+1K241702CROSSLEAD 0.014inchAsahi Intecc Co., Ltd.20250—
+1K241510CROSSLEAD TrackerAsahi Intecc Co., Ltd.20240—
+1K203529VASSALLO GT HybridFilmecc Co., Ltd.20211—
+1K203533Vassallo GTFilmecc Co., Ltd.20213—
+1K173277ASAHI PTCA Guide Wire ASAHI SION blackAsahi Intecc Co., Ltd.20180—
+2K232574VASSALLO GT Crossing14Filmec Co., Ltd.20230—
+2K232578Vassallo GT 018 G12; Vassallo GT 018 G30Filmec Co., Ltd.20230—
+2K223432Vassallo GT 018 HybridFilmecc Co., Ltd.20230—
+2K213949VASSALLO GT 018 FloppyFilmecc Co., Ltd.20220—