510(k) Report

Devices descending from K043398

10 later devices reach Modification to Vascupuncture Picc Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K112631Vsi GuidewireVascular Solutions, Inc.20117—
+1K070150Vascupuncture Picc GuidewireNeometrics, Inc.20071—
+2K223791TalWireEmbrace Medical, Ltd.20230—
+2K221390BNLE Access GuidewireBiomerics Nle20230—
+2K133114Micropuncture Introducer SetCook Incorporated20144—
+2K101729Neowire Pta/Ptca GuidewireNeometrics, Inc.20100—
+3K172980Micropuncture Pedal Access SetCook Incorporated20180—
+3K171275Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design…Cook Incorporated20172—
+4K253526NAMIC Dilator and SheathMedline Industries, LP20260—
+4K240589Micropuncture Introducer Sets; Micropuncture Pedal Access SetsCook Medical20240—