510(k) Report

Devices descending from K930622

13 later devices reach Amplatz Guidewires through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143613PaxWire Occlusion Balloon SystemAccessclosure, Inc.201501
+1K130798Pre-Formed GuidewiresLake Region Medical, Inc.201311—
+2K153397S-Wire Guidewire SystemConcert Medical, LLC20161—
+2K151244Pre-Formed GuidewireLake Region Medical201510—
+3K250031Amplatzer GuidewireAbbott Medical20250—
+3K221575Pre-Formed BlueLake Region Medical20220—
+3K213854SavvyWireOpsens, Inc.20224—
+3K211741Pre-Formed Extra Support GuidewireLake Region Medical20210—
+3K171445Amplatz Support Wire Guide with Apex CurveCook Incorporated20180—
+4K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc.20260—
+4K241418OptoMonitor 3Opsens, Inc.20251—
+4K240864PacePro WireOpsens, Inc.20240—
+5K251367OptoMonitor 3Opsens, Inc.20260—