510(k) Report

Devices descending from K111010

4 later devices reach Spiderfx Embolic Protection Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionContego Medical, LLC20180—
+1K180023WirionGardia Medical, Ltd.20182—
+2K200198WirionCardiovascular Systems, Inc.20201—
+3K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc.20210Class I