510(k) Report

Devices descending from K093911

4 later devices reach Fogarty Occlusion Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160598REBOA Balloon CatheterNuMED, Inc.20160—
+1K152762Fogarty Occlusion CatheterEdwards Lifesciences, LLC20152—
+1K132022Lemaitre 8F Occlusion CatheterLeMaitre Vascular, Inc.201301
+2K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLC20220—