510(k) Report

Devices descending from K961980

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041293Biopore Balloon Dilation CatheterBipore, Inc.20040—
+1K973563Bipore Balloon Dilatation CatheterBipore, Inc.19980—