510(k) Report

Devices descending from K141148

2 later devices reach Evolution RL Controlled-Rotation Dilator Sheath Set, Evolution Shortie RL… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K261310FlexTract Deflectable-Rotational Dilator Sheath SetMerit Medical Systems, Inc.20260—
+1K142301Evolution Mechanical Dilator Sheath Set, Evolution Shortie Mechanical Dilator Sheath…Cook Vascular, Inc.20140—