510(k) Report

Devices descending from K102035

2 later devices reach Sleek Otw Pta Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K221832SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation CatheterCordis US Corp20220—
+1K130786Sleek Otw Pta CatheterC.R. Bard, Inc.20130—