510(k) Report

Devices descending from K961859

5 later devices reach Novus Standard and Pediatric Valves through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to…Integra LifeSciences Corporation20160—
+1K020728Miethke Shunt SystemAesculap, Inc.200221
+1K974708Gemini Standard and Mini ValvesNeurocare Group19981—
+2K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc.20240—
+2K200950Ventricular CatheterAesculap, Inc.20200—