510(k) Report

Devices descending from K151638

6 later devices reach Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213451Spartan MC 0165Spartan Micro20210—
+1K210230Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20212—
+1K180959Phenom 27 CatheterCathera, Inc.20184—
+2K260199SLIM MicrocatheterBalt USA, LLC20260—
+2K251668SurfRider 13 MicrocatheterKaneka Americas Holding, Inc.20260—
+2K222023RayFlowHexacath20230—