510(k) Report

Devices descending from K090364

10 later devices reach Extra Pta Balloon Catheter with Embolic Protection Feature through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111010Spiderfx Embolic Protection DeviceEv3, Inc.20114—
+1K111750Extra Pta Balloon Catheter with Embolic Capture Feature; Proteus Pta Balloon Catheter…Angioslide, Ltd.20115—
+2K181529Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic ProtectionContego Medical, LLC20180—
+2K180023WirionGardia Medical, Ltd.20182—
+2K120164Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20120—
+2K120805Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20123—
+3K200198WirionCardiovascular Systems, Inc.20201—
+3K133043Proteus Pta Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20132—
+4K210282WIRION Embolic Protection SystemCardiovascular Systems, Inc.20210Class I
+4K172494PROTEUS PTA Balloon Catheter with Embolic Capture FeatureAngioslide, Ltd.20171—