510(k) Report

Devices descending from K030135

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113196Vascular SonoPAJUNK GmbH Medizintechnologie20120—
+1K050023Secureloc; AdvancintroducerSpecialized Health Products, Inc.20055—
+2K142445Pinpoint GT Safety Introducer NeedleC.R. Bard, Inc.20151—
+2K140513Merit Safety Introducer NeedleMerit Medical Systems, Inc.20140—
+2K070449Lumiloc (TM) Safety Introducer NeedleSpecialized Health Products International, Inc.20071—
+3K180725Aspire Introducer NeedleAspire Bariatrics, Inc.20180—
+3K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc.20160—