510(k) Report

Devices descending from K993257

16 later devices reach .010 Silverspeed Hydropophilic Guidewire, .014 Silversped Hydrophilic… 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—
+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—
+1K093681Meridian GuidewireEv3 Neurovascular20100—
+2K243383CHIKAI Nexus 014Asahi Intecc Co., Ltd.20250—
+2K240871Synxess Neurovascular GuidewireEnlight Medical Technologies (Shenzhen) Co., Ltd.20240—
+2K193548Mirage Hydrophilic Guidewire, X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20201—
+2K191714ASAHI Neurovascular Guide Wire CHIKAI X 014 softAsahi Intecc Co., Ltd.20190—
+2K183070ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010Asahi Intecc Co., Ltd.20190—
+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—
+2K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd.20160—
+2K160659ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)Asahi Intecc Co., Ltd.20160—
+3K201690Mirage Hydrophilic Guidewire; X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20200—