510(k) K223330 ยท JXG Shunt, Central Nervous System And Components
Certas Plus Programmable Valves
| Applicant | Integra Lifesciences Production Corporation, Mansfield MA, US |
| Decision | Substantially Equivalent, Feb 1, 2023 |
| Received | Oct 31, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223330
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 17, 2025 | Integra LifeSciences Corp. CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL.
Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hy Open, Classified |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.