510(k) K210993 ยท GWM Device, Monitoring, Intracranial Pressure
CereLink ICP Monitor
| Applicant | Integra Lifesciences Production Corporation, Mansfield MA, US |
| Decision | Substantially Equivalent, Apr 30, 2021 |
| Received | Apr 2, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K210993
| 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 |
| Jul 22, 2022 | Integra LifeSciences Corp. CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor. Open, Classified |
GWM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.