510(k) Report

Devices descending from K952860

19 later devices reach The Niner Nitinol Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K983033Acs HT Balance Middleweight Guide WireGuidant Corp.199817—
+1K954642Hydro-Select GuidewireMicrovena Corp.19960—
+2K092965Trailrunner GuidewiresLake Region Mfg., Inc.20100—
+2K030617PT2 Guide Wire and Addwire Extension WireBoston Scientific Scimed, Inc.2003114
+2K021285HI-Torque Extra S'port GuidewireGuidant Corp.20023—
+3K180726Savion DLVR Guidewire, Savion FLX GuidewireBoston Scientific, Inc.20180—
+3K151840Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch…Boston Scientific Corporation20150—
+3K143587ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix…Boston Scientific Corporation201561
+3K052965Easytrak 2 Stylet, Models 4826, 4829, 4832.Guidant Corporation20060—
+3K032183IQ Hydrophilic Guide WireBoston Scientific Corp20034—
+3K023300HI-Torque Whisper LS; HI-Torque Whisper MS; HI-Torque Whisper MS CS-J; HI-Torque Whisper…Guidant Corp.20021—
+4K170532True Form Reshapable Guide WireMerit Medical Systems, Inc.20170—
+4K152231Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 GuidewireBoston Scientific Corporation20162—
+4K041762Finishing Wire SupportrakGuidant Corporation20040—
+4K040140IQ Guide WireBoston Scientific Corp200431
+5K193194CrossTorq 14 GuidewireScientia Cardio Access, LLC20190—
+5K180795JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 GuidewireBoston Scientific20180—
+5K081021Kinetix Guidewire, Plus GuidewireBoston Scientific Corp20081—
+5K052783Modification to: IQ Guide Wire, Models 38950-XX. 38951-XXBoston Scientific Corp20050—