510(k) Report

Devices descending from K063371

27 later devices reach Pronto V3 Extraction Catheter, Model 5003 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K131998Aspire RX-LP6 Aspiration CatheterControl Medical Technology, LLC20131—
+1K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC20125—
+1K100569Merit Embolectomy Catheter Model ASAP100Merit Medical Systems, Inc.20112—
+1K083784Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010…Vascular Solutions, Inc.200910—
+1K073627Flexor Evac Aspiration CatheterCook, Inc.20080—
+1K072810Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc.200711—
+1K071727QXT Extraction CatheterVascular Solutions, Inc.200712—
+1K070363Fetch Aspiration CatheterPossis Medical, Inc.20072—
+2K220780ROVO Mechanical Thrombectomy Device2mg, Inc.20231—
+2K212199ASAP Aspiration Catheter, ASAPLP Aspiration CatheterMerit Medical Systems, Inc.20210—
+2K200629Aspire Mechanical Aspirator GControl Medical Technology20200—
+2K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorControl Medical Technology20201—
+2K162467Twin-Pass TorqueVascular Solutions, Inc.20172—
+2K132155Merit ASAPLP Aspiration CatheterMerit Medical Systems, Inc.20131—
+2K112382Terumo Aspriation CatheterTerumo Medical Corporation20110—
+2K103405Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4…Vascular Solutions, Inc.201041
+2K090977Piggyback Wire ConverterVascular Solutions, Inc.20090—
+2K081989Modification to Fetch Aspiration CatheterPossis Medical, Inc.20081—
+3K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.20260—
+3K250013VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S…Control Medical Technology, Inc. / Dba Ventiv Scientific20250—
+3K200324NHancer RxImds Operations B.V.20201—
+3K161506Penumbra Aspiration SystemPenumbra, Inc.20163—
+3K101354Fetch 2 Aspiration Catheter Model 109400-001Medrad Interventional/Possis20110Class I
+4K210431ReCrossImds Operations B.V.20210—
+4K163618INDIGO Aspiration SystemPenumbra, Inc.20172—
+5K180412Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and CanisterPenumbra, Inc.20181—
+6K220683INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)Penumbra, Inc.20220—