510(k) Report

Devices descending from K897106

3 later devices reach Medi-Tech Dilatation Catheters Ultra Thin II through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K961980Bipore Balloon Dilatation CatheterBipore, Inc.19962—
+2K041293Biopore Balloon Dilation CatheterBipore, Inc.20040—
+2K973563Bipore Balloon Dilatation CatheterBipore, Inc.19980—