510(k) Report

Devices descending from K941269

3 later devices reach Gore Smoother II and Gore BPTB through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K962765Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers) and (Wizdom…Cordis Corp.19972—
+2K993248Amplatzer Sizing BalloonAga Medical Corp.20001—
+3K053440Amplatzer Sizing Balloon IIAga Medical Corp.200502