510(k) Report

Devices descending from K050964

10 later devices reach PV 1900 Synchro 0.016 Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053268PVS 2000 SYNCHRO2 GuidewireBoston Scientific - Precision Vascular2006913
+2K222690SmartGUIDE deflectable hydrophilic guidewireArtiria Medical SA20230—
+2K202522Synchro SELECT GuidewireStryker Neurovascular202061
+2K190843Synchro2 Support GuidewireStryker201918
+3K252122DCwire Micro-guidewireShanghai Achieva Medical Suzhou Co., Ltd.20260—
+3K2437560.014” Willow GuidewireArbor Endovascular, LLC20254—
+4K2531680.014” Willow GuidewireArbor Endovascular, LLC20253—
+5K262424Willow 12 GuidewireArbor Endovascular, LLC20260—
+5K260130Willow 18 GuidewireArbor Endovascular, LLC20261—
+6K260537Willow 24 GuidewireArbor Endovascular, LLC20260—