510(k) Report

Devices descending from K020680

35 later devices reach Prowler Select 10 and 14 Infusion Catheters with and Without Pre-Shaped Tips through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.200417—
+1K021591Prowler Select (10, 14, and Plus) Infusion Catheters with and Without Pre-Shaped TipsCordis Neurovascular, Inc.2002162
+2K214025PROWLER SELECT LP ES Microcatheter; PROWLER XS MicrocatheterMedos International SARL20221—
+2K210838Prowler Select Plus; Prowler EXMedos International SARL20210—
+2K151638Phenom 17 Catheter, Phenom 21 Catheter, Phenom 27 Catheter, Phenom Plus CatheterCathera, Inc.20156—
+2K113289Orion Micro CatheterMicro Therapeutics, Inc.20123—
+2K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc.200516—
+2K043538Hypertransit Infusion CatheterCordis Neurovascular, Inc.20051—
+3K223139Wallaby 017 Micro CatheterWallaby Medical20230—
+3K213451Spartan MC 0165Spartan Micro20210—
+3K210230Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20212—
+3K180959Phenom 27 CatheterCathera, Inc.20184—
+3K150894VIA 21 MicrocatheterSequent Medical, Inc.20152—
+3K120508Clearlumen Thrombectomy SystemWalk Vascular, LLC20123—
+3K080901Lbi Embolectomy SystemLumen Biomedical, Inc.20086—
+3K071762Omniwave Endovascular SystemOmnisonics Medical Technologies20071—
+3K070279Modification to Hypertransit Infusion CatheterCordis Neurovascular, Inc.20070—
+3K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc.20069—
+4K260199SLIM MicrocatheterBalt USA, LLC20260—
+4K251668SurfRider 13 MicrocatheterKaneka Americas Holding, Inc.20260—
+4K222023RayFlowHexacath20230—
+4K192135VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27)…MicroVention, Inc.201903
+4K172716V2K Rinspiration SystemV2k Medical, Inc.20180—
+4K162565VIA 17 MicrocatheterSequent Medical, Inc.20171—
+4K140296Clearlumen Thrombectomy SystemWalk Vascular, LLC20142—
+4K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC20125—
+4K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies20080—
+4K071826The Rinspirator, Models FG09770, FG08776, FG08777, FG08910Fox Hollow Technologies20070—
+5K220780ROVO Mechanical Thrombectomy Device2mg, Inc.20231—
+5K200629Aspire Mechanical Aspirator GControl Medical Technology20200—
+5K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorControl Medical Technology20201—
+5K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC20161—
+6K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.20260—
+6K250013VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S…Control Medical Technology, Inc. / Dba Ventiv Scientific20250—
+6K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC20170—