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Integra Lifesciences Production Corporation

FDA 510(k) & PMA Approved Devices — 9 products

Total Devices9
Categories2
Latest FDA decision2026-06-23
TypeNumberDevice NameCodeDateActions
510(k) K261004 Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)JXG2026-06-23 View
510(k) K243531 Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyJXG2025-08-08 View
510(k) K243552 Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)JXG2025-08-06 View
510(k) K232890 CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)GWM2024-02-04 View
510(k) K233445 Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular CatheterJXG2024-01-17 View
510(k) K233448 Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter SetJXG2023-12-19 View
510(k) K223330 Certas Plus Programmable ValvesJXG2023-02-01 View
510(k) K221840 Hakim Programmable Valves, Hakim Precision Fixed Pressure ValvesJXG2022-10-14 View
510(k) K210993 CereLink ICP MonitorGWM2021-04-30 View
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