510(k) Report

Devices descending from K954313

2 later devices reach Focus PC Balloon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K971577Focus-PV Balloon Dilatation CatheterCardiovascular Dynamics, Inc.19970—
+1K963688Focus PV Balloon Dilatation CatheterCardiovascular Dynamics, Inc.19970—