510(k) Report

Devices descending from K931027

19 later devices reach Bullett Peripheral Infusion Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971619Microfuse Membrane Infusion CatheterE-Med Corp.199818—
+2K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.200417—
+3K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc.200516—
+4K120508Clearlumen Thrombectomy SystemWalk Vascular, LLC20123—
+4K080901Lbi Embolectomy SystemLumen Biomedical, Inc.20086—
+4K071762Omniwave Endovascular SystemOmnisonics Medical Technologies20071—
+4K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc.20069—
+5K172716V2K Rinspiration SystemV2k Medical, Inc.20180—
+5K140296Clearlumen Thrombectomy SystemWalk Vascular, LLC20142—
+5K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC20125—
+5K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies20080—
+5K071826The Rinspirator, Models FG09770, FG08776, FG08777, FG08910Fox Hollow Technologies20070—
+6K220780ROVO Mechanical Thrombectomy Device2mg, Inc.20231—
+6K200629Aspire Mechanical Aspirator GControl Medical Technology20200—
+6K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorControl Medical Technology20201—
+6K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC20161—
+7K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.20260—
+7K250013VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S…Control Medical Technology, Inc. / Dba Ventiv Scientific20250—
+7K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC20170—