510(k) K232890 ยท GWM Device, Monitoring, Intracranial Pressure
CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845)
| Applicant | Integra Lifesciences Production Corporation, Mansfield MA, US |
| Decision | Substantially Equivalent, Feb 4, 2024 |
| Received | Sep 18, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232890
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2023 | Integra LifeSciences Corp. CereLink ICP Extension Cable (Extension Cable), Model No. 826845
Used with Codman CereLink Intracranial Pressure (ICP) Monitor, Model No. 826820/826820P. Cable is also provided with monitor as part o Open, Classified |
GWM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.