510(k) Report

Devices descending from K040345

11 later devices reach Modification to Nitrex Nitinol Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160643ENROUTE 0.014 GuidewireLake Region Medical20161—
+1K050756Skipper and Skipper Race GuidewireInvatec Innovative Technologies, S.R.L.200510—
+2K253746Enroute 0.014'' Transcarotid GuidewireLake Region Medical20260—
+2K060551Brivant GuidewireBrivant Limited20069—
+3K103377Charter Guidewire Model 45-281, 45-282, 45-283Brivant, Ltd.20112—
+3K102211Cruiser 18 GuidewireBrivant, Ltd.20101—
+3K0935153 Piece Parodi Guidewire System ( Long Cut Outer with Long Taper .014) Short Taper, 2…Brivant, Ltd.20100—
+3K083094Streamer Polymer GuidewireBrivant, Ltd.20093—
+4K141831Hydraview GuidewireBrivant Limited20140—
+4K122856Charter GuidewireBrivant, Ltd.20120—
+4K120137Victory Guidewire (32 Models)Brivant, Ltd.20120—