510(k) Report

Devices descending from K101339

13 later devices reach Archer Super Stiff Guidewires through their predicates, nearest generation first.

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