510(k) Report

Devices descending from K053350

5 later devices reach Modification to Codman Hakim Shunt Systems through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc.201731
+1K122118Hakim Programmable and Precision Valve Shunt SystemCodman & Shurtleff, Inc.20124—
+2K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic…Integra Lifesciences Production Corporation20241—
+2K221840Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesIntegra Lifesciences Production Corporation20220—
+3K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation20250—