510(k) K243552 · JXG Shunt, Central Nervous System And Components
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, Mansfield MA, US |
| Decision | Substantially Equivalent, Aug 6, 2025 |
| Received | Nov 15, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243552
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.