510(k) Report

Devices descending from K112631

7 later devices reach Vsi Guidewire through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223791TalWireEmbrace Medical, Ltd.20230—
+1K221390BNLE Access GuidewireBiomerics Nle20230—
+1K133114Micropuncture Introducer SetCook Incorporated20144—
+2K172980Micropuncture Pedal Access SetCook Incorporated20180—
+2K171275Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design…Cook Incorporated20172—
+3K253526NAMIC Dilator and SheathMedline Industries, LP20260—
+3K240589Micropuncture Introducer Sets; Micropuncture Pedal Access SetsCook Medical20240—