Medical Device Manufacturer · US , Mansfield , MA

Integra Lifesciences Production Corporation - FDA 510(k) Cleared Devi...

9 submissions · 9 cleared · Since 2021

Recent clearances: Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology, Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761), CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)

9

Total

9

Cleared

0

Denied

FDA 510(k) Regulatory Record - Integra Lifesciences Production Corporation Neurology ✕

9 devices

1-9 of 9

Cleared Jun 23, 2026

Codman® Distal Peritoneal Catheter, Barium Open End (82-1682)

Neurology · 89d

Cleared Aug 08, 2025

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology

Neurology · 267d

Cleared Aug 06, 2025

Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology...

Neurology · 264d

Cleared Feb 04, 2024

CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)

Neurology · 139d

Cleared Jan 17, 2024

Bactiseal Catheters

Neurology · 90d

Cleared Dec 19, 2023

Bactiseal EVD Catheter Sets

Neurology · 60d

Cleared Feb 01, 2023

Certas Plus Programmable Valves

Neurology · 93d

Cleared Oct 14, 2022

Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves

Neurology · 112d

Cleared Apr 30, 2021

CereLink ICP Monitor

Neurology · 28d