FDA 510(k)

Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology

Numéro K : K243531 · 2025-08-08

DemandeurIntegra Lifesciences Production Corporation

Date de décision2025-08-08

Code produitJXG

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Integra Lifesciences Production Corporation. The 510(k) number is K243531.

When did Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology receive FDA 510(k) clearance?

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

Who is the listed applicant for Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology?

The FDA 510(k) record lists Integra Lifesciences Production Corporation as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Autres dossiers indiquant Integra Lifesciences Production Corporation en tant que demandeur

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)K243552Codman 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)K232890CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)K233445Bactiseal Catheters; Bactiseal Barium Striped Catheters; Bactiseal Endoscopic Ventricular Catheter K233448Bactiseal EVD Catheter Sets; Bactiseal Clear EVD Catheter Set K223330Certas Plus Programmable Valves

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Dispositifs connexes (Code : JXG)

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production Corporation K251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)Sophysa K252514EVAC-MRIPhasor Health, LLC K243552Codman 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)Integra Lifesciences Production Corporation K242974External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar CathetersSophysa

Source officielle

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