510(k) Report

Devices descending from K083146

17 later devices reach Asahi Regalia XS 1.0 Peripheral Guide Wire, Models Pagp 140000 & Pagp 1403000 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241510CROSSLEAD TrackerAsahi Intecc Co., Ltd.20240—
+1K163426ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire ExtensionAsahi Intecc Co., Ltd.201711—
+1K150445ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)Asahi Intecc Co., Ltd.201516—
+2K243733SION blue PLUSAsahi Intecc Co., Ltd.20250—
+2K241962CrossloopAsahi Intecc Co., Ltd.20250—
+2K241702CROSSLEAD 0.014inchAsahi Intecc Co., Ltd.20250—
+2K213868ASAHI Gladius Mongo18 PV ESAsahi Intecc Co., Ltd.20221—
+2K212268FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXTFMD Co., Ltd.20221—
+2K203529VASSALLO GT HybridFilmecc Co., Ltd.20211—
+2K203533Vassallo GTFilmecc Co., Ltd.20213—
+2K173277ASAHI PTCA Guide Wire ASAHI SION blackAsahi Intecc Co., Ltd.20180—
+3K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD…FMD Co., Ltd.20260—
+3K242597CROSSLEAD 0.018inchAsahi Intecc Co., Ltd.20250—
+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—