510(k) Report

Devices descending from K010497

3 later devices reach Silverspeed Hydrophilic Guidewire, Models 103-0601-300 and 103-0602-300 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K124007Silverspeed Hydrophilic Guidewire, X-Celerator Hydrophilic Exchange Guidewire, X-Pedion…Micro Therapeutics, Inc. D/B/A: Ev3, Inc.20132—
+2K193548Mirage Hydrophilic Guidewire, X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20201—
+3K201690Mirage Hydrophilic Guidewire; X-pedion Hydrophilic GuidewireMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20200—