510(k) Report

Devices descending from K031173

3 later devices reach Needletech Guidewire Introducer Needle, Models 40021, 40069, 40053, 40042 &… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K101312Nuvue COLORMARK9TM) NeedleNuvue Therapeutics, Inc.20110—
+1K040029Safetynet Guidewire IntroducerInjectimed, Inc.20041—
+2K073664Frontline Medical Safetynet Guidewire IntroducerInjectimed, Inc.20080—