510(k) Report

Devices descending from K063442

2 later devices reach All Silicone Foley Catheter, 2-Way, 3-Way, with Temperature Sensor through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172422Kohli Urinary Drainage CatheterNellie Medical, LLC20180—
+1K103371Coude/ or TiemannDegania Silicone, Ltd.20110—