510(k) Report

Devices descending from K020283

14 later devices reach Back-UP Meier Steerable Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101339Archer Super Stiff GuidewiresMedtronic, Inc.2010132
+2K232570Steerant™ Super Stiff GuidewireMedtronic Vascular20230—
+2K132623Medtronic Confida Brecker Curve GuidewireMedtronic201311—
+3K213898ProTrack Pigtail WireBaylis Medical Company, Inc.20230—
+3K150465Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC20159—
+4K181001Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC20188—
+5K250075Medtronic Stedi Extra Support GuidewireMedtronic, Inc.20250—
+5K192454Wattson Temporary Pacing GuidewireVascular Solutions20206—
+6K230637Wattson temporary pacing guidewire (2250)Vascular Solutions, LLC20230—
+6K213854SavvyWireOpsens, Inc.20224—
+7K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc.20260—
+7K241418OptoMonitor 3Opsens, Inc.20251—
+7K240864PacePro WireOpsens, Inc.20240—
+8K251367OptoMonitor 3Opsens, Inc.20260—