510(k) Report

Devices descending from K800298

10 later devices reach Usci Bipolar Ballon Pacing Electrode through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K192454Wattson Temporary Pacing GuidewireVascular Solutions20206—
+1K955712Usci Bipolar Balloon Pacing Electrode with BH CoatingC.R. Bard, Inc.19962—
+2K241334Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes…C.R. Bard, Inc.20251—
+2K230637Wattson temporary pacing guidewire (2250)Vascular Solutions, LLC20230—
+2K213854SavvyWireOpsens, Inc.20224—
+3K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc.20260—
+3K251186Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)C.R. Bard, Inc.20250—
+3K241418OptoMonitor 3Opsens, Inc.20251—
+3K240864PacePro WireOpsens, Inc.20240—
+4K251367OptoMonitor 3Opsens, Inc.20260—