510(k) Report

Devices descending from K883718

14 later devices reach Merit HI-Flex (TM) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K051917Diver C.E. CatheterInvatec Innovative Technologies, S.R.L.2005131
+2K071727QXT Extraction CatheterVascular Solutions, Inc.200712—
+3K072810Pronto Low Profile (LP) Extraction Catheter, Model 5010Vascular Solutions, Inc.200711—
+4K083784Pronto V3 Extraction Center, Model 5003, Pronto LP Extraction Catheter, Model 5010…Vascular Solutions, Inc.200910—
+5K162467Twin-Pass TorqueVascular Solutions, Inc.20172—
+5K112382Terumo Aspriation CatheterTerumo Medical Corporation20110—
+5K103405Pronto V4 Extraction Catheter 5.5F; Pronto V4 Extraction Catheter 6F; Pronto V4…Vascular Solutions, Inc.201041
+5K090977Piggyback Wire ConverterVascular Solutions, Inc.20090—
+6K200324NHancer RxImds Operations B.V.20201—
+6K161506Penumbra Aspiration SystemPenumbra, Inc.20163—
+7K210431ReCrossImds Operations B.V.20210—
+7K163618INDIGO Aspiration SystemPenumbra, Inc.20172—
+8K180412Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and CanisterPenumbra, Inc.20181—
+9K220683INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)Penumbra, Inc.20220—