510(k) Report

Devices descending from K053268

9 later devices reach PVS 2000 SYNCHRO2 Guidewire through their predicates, nearest generation first.

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