510(k) Report

Devices descending from K032146

28 later devices reach PVS 1300 Synchro 0.014 & PVS 1600 Synchro 0.010 Guide Wires through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K252122DCwire Micro-guidewireShanghai Achieva Medical Suzhou Co., Ltd.20260—
+1K173235Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support…Scientia Vascular, LLC201816—
+1K053268PVS 2000 SYNCHRO2 GuidewireBoston Scientific - Precision Vascular2006913
+1K050964PV 1900 Synchro 0.016 GuidewireBoston Scientific - Precision Vascular2005106
+2K253579Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…Scientia Vascular, Inc.20260—
+2K243938Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14…Scientia Vascular, Inc.20252—
+2K222690SmartGUIDE deflectable hydrophilic guidewireArtiria Medical SA20230—
+2K220398Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14…Scientia Vascular, LLC20231—
+2K202522Synchro SELECT GuidewireStryker Neurovascular202061
+2K201760Zoom 14 GuidewireScientia Vascular, LLC20206—
+2K190843Synchro2 Support GuidewireStryker201918
+2K183608Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard…Scientia Vascular, LLC201913—
+2K181828Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo…Scientia Vascular, LLC20182—
+3K260223Aristotle Mini GuidewireScientia Vascular, Inc.20260—
+3K252317Zenith Micro GuidewireSuzhou Zenith Vascular SciTech Limited20260—
+3K244061X-Wire GuidewireImperative Care, Inc.20250—
+3K2437560.014” Willow GuidewireArbor Endovascular, LLC20254—
+3K231954Aristotle 18 Guidewire; Aristotle 24 GuidewireScientia Vascular, Inc.20235—
+3K192783Aristotle 24 Guidewire, 200cm, Soft Profile ; Aristotle 24 Guidewire, 200cm, Standard…Scientia Vascular, LLC201912—
+4K2531680.014” Willow GuidewireArbor Endovascular, LLC20253—
+4K233791Drivewire 24 GuidewireRapid-Medical, Ltd.20241—
+4K222437Aristotle Colossus GuidewireScientia Vascular, Inc.20235—
+5K254181Aristotle 65 MacrowireScientia Vascular20260—
+5K26075135 Helix GuidewirePiraeus Medical, Inc.20260—
+5K262424Willow 12 GuidewireArbor Endovascular, LLC20260—
+5K254006Drivewire 35 GuidewireRapid Medical Ltd.20260—
+5K260130Willow 18 GuidewireArbor Endovascular, LLC20261—
+6K260537Willow 24 GuidewireArbor Endovascular, LLC20260—