510(k) Report

Devices descending from K130798

11 later devices reach Pre-Formed Guidewires through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153397S-Wire Guidewire SystemConcert Medical, LLC20161—
+1K151244Pre-Formed GuidewireLake Region Medical201510—
+2K250031Amplatzer GuidewireAbbott Medical20250—
+2K221575Pre-Formed BlueLake Region Medical20220—
+2K213854SavvyWireOpsens, Inc.20224—
+2K211741Pre-Formed Extra Support GuidewireLake Region Medical20210—
+2K171445Amplatz Support Wire Guide with Apex CurveCook Incorporated20180—
+3K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc.20260—
+3K241418OptoMonitor 3Opsens, Inc.20251—
+3K240864PacePro WireOpsens, Inc.20240—
+4K251367OptoMonitor 3Opsens, Inc.20260—