510(k) Report

Devices descending from K971254

39 later devices reach Transend EX Platinum Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K11345414 Wire Standard, 14 Wire LSMicro Therapeutics, Inc.20120—
+1K113716Asahi Chikai V Peripheral Vascular Guide WireAsahi Intecc Co., Ltd.20121—
+1K112979Asahi Chikai 10 Neurovascular Guide WireAsahi Intecc Co., Ltd.20116—
+1K110584Asahi Chikai Neurovascular Guide WireAsahi Intecc Co., Ltd.201111—
+1K080863Traxcess 0.014 Hydrophilic GuidewireMicroVention, Inc.200812—
+1K053265Micrus Guide Wire, Watusi 0.014Micrus Endovascular Corporation200601
+1K053268PVS 2000 SYNCHRO2 GuidewireBoston Scientific - Precision Vascular2006913
+1K051373Cronus Guidewire, Model 001-001470-1Stereotaxis, Inc.20050—
+1K050964PV 1900 Synchro 0.016 GuidewireBoston Scientific - Precision Vascular2005106
+2K240871Synxess Neurovascular GuidewireEnlight Medical Technologies (Shenzhen) Co., Ltd.20240—
+2K222690SmartGUIDE deflectable hydrophilic guidewireArtiria Medical SA20230—
+2K202522Synchro SELECT GuidewireStryker Neurovascular202061
+2K191714ASAHI Neurovascular Guide Wire CHIKAI X 014 softAsahi Intecc Co., Ltd.20190—
+2K190843Synchro2 Support GuidewireStryker201918
+2K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd.20160—
+2K160659ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)Asahi Intecc Co., Ltd.20160—
+2K141751Asahi Neurovascular Guide Wire Asahi Chikai 008, Asahi Neurovascular Guide Wire Asahi…Asahi Intecc Co., Ltd.20154—
+2K133725Traxcess 14 GuidewireMicroVention, Inc.20149—
+2K093397Traxcess 14EX Guidewire and Traxcess Docking WireMicroVention, Inc.20091—
+3K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited20260—
+3K252122DCwire Micro-guidewireShanghai Achieva Medical Suzhou Co., Ltd.20260—
+3K2437560.014” Willow GuidewireArbor Endovascular, LLC20254—
+3K243383CHIKAI Nexus 014Asahi Intecc Co., Ltd.20250—
+3K200374Columbus GuidewireRapid-Medical, Ltd.20200—
+3K191687pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension WirePhenox Limited20190—
+3K183070ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010Asahi Intecc Co., Ltd.20190—
+3K182337HYBRID GuidewireBalt USA, LLC20181—
+3K171613ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tipAsahi Intecc Co., Ltd.20170—
+3K161912ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tipAsahi Intecc Co., Ltd.20160—
+3K153053Traxcess Pro 14 GuidewireMicroVention, Inc.20154—
+4K252011CHIKAI Nexus petitAsahi Intecc Co., Ltd.20260—
+4K2531680.014” Willow GuidewireArbor Endovascular, LLC20253—
+4K200547Traxcess 14 SELECT GuidewireMicroVention, Inc.20200—
+4K161803Traxcess .007 Mini GuidewireMicroVention, Inc.201621
+5K262424Willow 12 GuidewireArbor Endovascular, LLC20260—
+5K260130Willow 18 GuidewireArbor Endovascular, LLC20261—
+5K201487Traxcess 7 Mini GuidewireMicroVention, Inc.20200—
+5K163154Traxcess 7 Mini XSoft GuidewireMicroVention, Inc.20160—
+6K260537Willow 24 GuidewireArbor Endovascular, LLC20260—