510(k) Report

Devices descending from K920884

28 later devices reach Guidewires, Various Types through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101199Guide Wire for Edi Catheter, 8FR,125CM,5 Each,Guide Wire for Edi Catheter, 8FR,125CM,5…Maquet Critical Care AB20101—
+1K982559GuidewireGalt Medical Corp.1999251
+2K182660GaltTWSGalt Medical Corp.20191—
+2K153461Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire…Maquet Critical Care AB20150—
+2K042370Torayguide GuidewireToray Industries (America), Inc.200413—
+2K033542Easy Pass Hydrophilic Coated Vascular GuidewireGalt Medical Corp.20030—
+2K031916Galt Medical GuidewireGalt Medical Corp.200311
+2K021990Galt Medical GuidewireGalt Medical Corp.200281
+3K220280Arrow Stiffening StyletArrow International, LLC (A subsidiary of Teleflex, Inc.)20220—
+3K151234R350 guidewireVascular Solutions, Inc.20155—
+3K132623Medtronic Confida Brecker Curve GuidewireMedtronic201311—
+3K111288Anchorwire GuidewireLake Region Medical20110—
+4K213898ProTrack Pigtail WireBaylis Medical Company, Inc.20230—
+4K161702Endura guidewireVascular Solutions, Inc.20164—
+4K150465Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC20159—
+5K181001Medtronic Confida Brecker GuidewireMedtronic Core Valve, LLC20188—
+5K163444Spectre guidewireVascular Solutions, Inc.20173—
+6K250075Medtronic Stedi Extra Support GuidewireMedtronic, Inc.20250—
+6K192454Wattson Temporary Pacing GuidewireVascular Solutions20206—
+6K180128Warrior 14 guidewireVascular Solutions, Inc.20180—
+6K173532Raider GuidewireVascular Solutions, Inc.20171—
+7K230637Wattson temporary pacing guidewire (2250)Vascular Solutions, LLC20230—
+7K213854SavvyWireOpsens, Inc.20224—
+7K181647Bandit guidewireVascular Solutions, Inc.20180—
+8K252674Solo Pace Fusion System (SOLOFUSE1)Solo Pace, Inc.20260—
+8K241418OptoMonitor 3Opsens, Inc.20251—
+8K240864PacePro WireOpsens, Inc.20240—
+9K251367OptoMonitor 3Opsens, Inc.20260—