510(k) Report

Devices descending from K151244

10 later devices reach Pre-Formed Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K250031Amplatzer GuidewireAbbott Medical20250—
+1K221575Pre-Formed BlueLake Region Medical20220—
+1K213854SavvyWireOpsens, Inc.20224—
+1K211741Pre-Formed Extra Support GuidewireLake Region Medical20210—
+1K153397S-Wire Guidewire SystemConcert Medical, LLC20161—
+2K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc.20260—
+2K241418OptoMonitor 3Opsens, Inc.20251—
+2K240864PacePro WireOpsens, Inc.20240—
+2K171445Amplatz Support Wire Guide with Apex CurveCook Incorporated20180—
+3K251367OptoMonitor 3Opsens, Inc.20260—