510(k) Report

Devices descending from K100930

14 later devices reach Primewire Prestiage Pressure Guide Wire, Models 8185, 8185J, 8300, 8300J through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111395Primewire Prestige PlusVolcano Corporation2011131
+2K201720LiPPS Analyzer, LiPPS Wire Pressure Guide WireBeijing Bywave Sensing Medical Technology Co., Ltd.20210—
+2K192340OptoMonitorOpsens, Inc.20197—
+2K161263OptoMonitor IIOpsens, Inc.20160—
+2K142598Opto Wire and OptoMonitor SystemOpsens, Inc.201512—
+3K202943OptoMonitor 3Opsens, Inc.20205—
+3K193620OptoMonitor 3Opsens, Inc.20206—
+3K152991OptoWire DeuxOpsens20166—
+4K213854SavvyWireOpsens, Inc.20224—
+4K191907OptoWire IIIOpsens, Inc.20205—
+5K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc.20260—
+5K241418OptoMonitor 3Opsens, Inc.20251—
+5K240864PacePro WireOpsens, Inc.20240—
+6K251367OptoMonitor 3Opsens, Inc.20260—