510(k) Report

Devices descending from K063204

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222694EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)MicroVention, Inc.20230—
+1K111010Spiderfx Embolic Protection DeviceEv3, Inc.20114—
+1K103500Gore Embolic FilterW. L. Gore & Associates, Inc.20111—
+2K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionContego Medical, LLC20180—
+2K180023WirionGardia Medical, Ltd.20182—
+2K120480Gore (R) Embolic FilterW.L. Gore & Associates20120—
+3K200198WirionCardiovascular Systems, Inc.20201—
+4K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc.20210Class I