510(k) Report

Devices descending from K962765

2 later devices reach Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K993248Amplatzer Sizing BalloonAga Medical Corp.20001—
+2K053440Amplatzer Sizing Balloon IIAga Medical Corp.200502