510(k) Report

Devices descending from K003322

13 later devices reach Codman Bactiseal Catheters through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110560Medtronic Ares Antibiotic-Impregnated CatheterMedtronic Neurosurgery201113
+1K110751Codman Bactiseal Endoscopic Venticular CatheterCodman & Shurtleff, Inc.201121
+1K102589Codman Bactiseal Catheters, Codman Bactiseal Evd CatheterCodman & Shurtleff, Inc.20114—
+1K020667Codman Hakim Shunt SystemsCodman & Shurtleff, Inc.20028—
+2K242003XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter SetAesculap, Inc.20240—
+2K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic…Integra Lifesciences Production Corporation20241—
+2K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc.201731
+2K122118Hakim Programmable and Precision Valve Shunt SystemCodman & Shurtleff, Inc.20124—
+2K091346Codman Hakim Micro II ValveCodman & Shurtleff, Inc.20090—
+2K053350Modification to Codman Hakim Shunt SystemsCodman & Shurtleff, Inc.20065—
+2K053107Codman Hakim Programmable Valve W/WO SiphonguardCodman & Shurtleff, Inc.20060—
+3K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation20250—
+3K221840Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesIntegra Lifesciences Production Corporation20220—