510(k) Report

Devices descending from K070879

2 later devices reach Bard Malecot and Pezzer Drains through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K191512LotusCatheter (Lotus No Balloon Catheter)Hakki Medical Technologies, Inc.20200—
+1K101900Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 FrenchHakki Medical Technologies, Inc.20111—