510(k) Report

Devices descending from K021653

8 later devices reach Codman Bactiseal Evd Catheter Set through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetIntegra Lifesciences Production Corporation202313
+1K102589Codman Bactiseal Catheters, Codman Bactiseal Evd CatheterCodman & Shurtleff, Inc.20114—
+1K090348Codman Bactiseal Evd Catheter Set, Codman Bactiseal Clear Evd Catheter SetCodman & Shurtleff, Inc.20092—
+2K243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer…Integra Lifesciences Production Corporation20250—
+2K172022CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)Codman & Shurtleff, Inc.201731
+3K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic…Integra Lifesciences Production Corporation20241—
+3K221840Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesIntegra Lifesciences Production Corporation20220—
+4K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation20250—