510(k) Report

Devices descending from K011085

13 later devices reach Guidewire Introducer Safety Needle through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K040029Safetynet Guidewire IntroducerInjectimed, Inc.20041—
+1K030135Safety Introducer NeedleB.Braun Medical, Inc.20037—
+1K022117Majestik (TM) Shielded Angiography Needle, Model STAN18T71W-25, Majestik (TM) Shielded…Merit Medical Systems, Inc.20020—
+1K020563Medamicus Axia RSNMedamicus, Inc.20023—
+2K113196Vascular SonoPAJUNK GmbH Medizintechnologie20120—
+2K073664Frontline Medical Safetynet Guidewire IntroducerInjectimed, Inc.20080—
+2K050023Secureloc; AdvancintroducerSpecialized Health Products, Inc.20055—
+2K022689Modification to Medamicus Axia RSNMedamicus, Inc.20022—
+3K142445Pinpoint GT Safety Introducer NeedleC.R. Bard, Inc.20151—
+3K140513Merit Safety Introducer NeedleMerit Medical Systems, Inc.20140—
+3K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc.20071—
+4K180725Aspire Introducer NeedleAspire Bariatrics, Inc.20180—
+4K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc.20160—