510(k) Report

Devices descending from K002212

38 later devices reach Mirage Hydrophilic Guidewire, Model 103-0608 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141751Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular Guide Wire Asahi…Asahi Intecc Co., Ltd.20154—
+1K124007Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange Guidewire, X-Pedion…Micro Therapeutics, Inc. D/B/A: Ev3, Inc.20132—
+1K032146PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide WiresPrecision Vascular Systems, Inc.2003281
+1K023700PVS 1600 Synchro 0.010 Neuro Guide WirePrecision Vascular Systems, Inc.200201
+2K252122DCwire Micro-guidewireShanghai Achieva Medical Suzhou Co., Ltd.20260—
+2K243383CHIKAI Nexus 014Asahi Intecc Co., Ltd.20250—
+2K193548Mirage Hydrophilic Guidewire, X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20201—
+2K183070ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010Asahi Intecc Co., Ltd.20190—
+2K173235Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support…Scientia Vascular, LLC201816—
+2K171613ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tipAsahi Intecc Co., Ltd.20170—
+2K161912ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tipAsahi Intecc Co., Ltd.20160—
+2K053268PVS 2000 SYNCHRO2 GuidewireBoston Scientific - Precision Vascular2006913
+2K050964PV 1900 Synchro 0.016 GuidewireBoston Scientific - Precision Vascular2005106
+3K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…Scientia Vascular, Inc.20260—
+3K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…Scientia Vascular, Inc.20252—
+3K222690SmartGUIDE deflectable hydrophilic guidewireArtiria Medical SA20230—
+3K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14…Scientia Vascular, LLC20231—
+3K202522Synchro SELECT GuidewireStryker Neurovascular202061
+3K201760Zoom 14 GuidewireScientia Vascular, LLC20206—
+3K201690Mirage Hydrophilic Guidewire; X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20200—
+3K190843Synchro2 Support GuidewireStryker201918
+3K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard…Scientia Vascular, LLC201913—
+3K181828Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo…Scientia Vascular, LLC20182—
+4K260223Aristotle Mini GuidewireScientia Vascular, Inc.20260—
+4K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited20260—
+4K244061X-Wire GuidewireImperative Care, Inc.20250—
+4K2437560.014” Willow GuidewireArbor Endovascular, LLC20254—
+4K231954Aristotle 18 Guidewire; Aristotle 24 GuidewireScientia Vascular, Inc.20235—
+4K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard…Scientia Vascular, LLC201912—
+5K2531680.014” Willow GuidewireArbor Endovascular, LLC20253—
+5K233791Drivewire 24 GuidewireRapid-Medical, Ltd.20241—
+5K222437Aristotle Colossus GuidewireScientia Vascular, Inc.20235—
+6K254181Aristotle 65 MacrowireScientia Vascular20260—
+6K26075135 Helix GuidewirePiraeus Medical, Inc.20260—
+6K262424Willow 12 GuidewireArbor Endovascular, LLC20260—
+6K254006Drivewire 35 GuidewireRapid Medical Ltd.20260—
+6K260130Willow 18 GuidewireArbor Endovascular, LLC20261—
+7K260537Willow 24 GuidewireArbor Endovascular, LLC20260—