510(k) Report

Devices descending from K952063

1 later device reach XXL Ballon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K970725Opti-Plast XL 5.5 F Pta CatheterVas-Cath, Inc.19970—