510(k) Report

Devices descending from K021591

16 later devices reach Prowler Select (10, 14, and Plus) Infusion Catheters with and Without… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K214025PROWLER SELECT LP ES Microcatheter; PROWLER XS MicrocatheterMedos International SARL20221—
+1K210838Prowler Select Plus; Prowler EXMedos International SARL20210—
+1K151638Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus CatheterCathera, Inc.20156—
+1K113289Orion Micro CatheterMicro Therapeutics, Inc.20123—
+1K043538Hypertransit Infusion CatheterCordis Neurovascular, Inc.20051—
+2K223139Wallaby 017 Micro CatheterWallaby Medical20230—
+2K213451Spartan MC 0165Spartan Micro20210—
+2K210230Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20212—
+2K180959Phenom 27 CatheterCathera, Inc.20184—
+2K150894VIA 21 MicrocatheterSequent Medical, Inc.20152—
+2K070279Modification to Hypertransit Infusion CatheterCordis Neurovascular, Inc.20070—
+3K260199SLIM MicrocatheterBalt USA, LLC20260—
+3K251668SurfRider 13 MicrocatheterKaneka Americas Holding, Inc.20260—
+3K222023RayFlowHexacath20230—
+3K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27)…MicroVention, Inc.201903
+3K162565VIA 17 MicrocatheterSequent Medical, Inc.20171—