510(k) Report

Devices descending from K101604

6 later devices reach Vsi Micro-Introducer Sets (Regular, Stiffen), Models 7197V-7209V, 7240V-7256V… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K180913VSI Micro-Introducer KitVascular Solutions, Inc.20180—
+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—