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)

510(k) number: K243552
Device name: 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)
Applicant: Integra Lifesciences Production Corporation MA · US
Product code: JXG — Shunt, Central Nervous System And Components
Decision date: 2025-08-06
Date received: 2024-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Neurology

PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain

Also available from FDA: K243552.pdf

Official FDA record: K243552

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.