FDA 510(k)

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology

K-Number: K243531 · 2025-08-08

ApplicantIntegra Lifesciences Production Corporation

Decision Date2025-08-08

Product CodeJXG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology is a medical device manufactured by Integra Lifesciences Production Corporation. It received FDA 510(k) clearance on 2025-08-08 under approval number K243531. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology?

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology is a medical device that received FDA 510(k) clearance on 2025-08-08. It is manufactured by Integra Lifesciences Production Corporation. The 510(k) number is K243531.

When was Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology approved by the FDA?

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology received FDA 510(k) clearance on 2025-08-08, under approval number K243531.

What company makes Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology?

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology is manufactured by Integra Lifesciences Production Corporation.

What is the FDA product code for Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology?

The FDA product code for Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology is JXG.

Related Clinical Trials

NCT06808217 A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation ACTIVE_NOT_RECRUITING NCT07587541 Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter NOT_YET_RECRUITING NCT07572253 A Study of Using CARTO SOUND™ FAM to Guide Pulsed Field Ablation for Atrial Fibrillation NOT_YET_RECRUITING NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING NCT06816368 Combined Pulsed Field and Radiofrequency Energy for Ablation of Ventricular Tachycardia ACTIVE_NOT_RECRUITING NCT07542938 Medeliver Intracranial Drug Coated Balloon Catheter for Symptomatic Intracranial Atherosclerotic Stenosis NOT_YET_RECRUITING

Other Devices by Integra Lifesciences Production Corporation

K210993CereLink ICP Monitor K221840Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set K223330Certas Plus Programmable Valves K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter

View all 8 devices →

Related Devices (Code: JXG)

K162437Codman EDS3 CSF External Drainage SystemCodman & Shurtleff, Inc. K161605Smart External Drain (SED) SystemAqueduct Critical Care, Inc. K161992Horizontal-Vertical Lumbar Valve Systems, Spetzler Lumbar Peritoneal Shunt SystemsIntegra LifeSciences Corporation K152700StrataMR Valves and ShuntsMedtronic Neurosurgery K153041Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional LabelingIntegra LifeSciences Corporation K152897Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating AccessoryIntegra LifeSciences Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.