510(k) Report

Devices descending from K961438

2 later devices reach Ballon Dilatation Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K973113Modified Olbert Balloon Catheter System, Noprofile Olbert Balloon Catheter SystemBoston Scientific Corp19971—
+2K010714Expander, Models 1400880, 1401280, 1401680, 1401880, 1410420, 1410620, 1410830Medi-Globe Corp.20030—