510(k) K974088 ยท GWM Device, Monitoring, Intracranial Pressure
CODMAN INTRACRANIAL BOLT
| Applicant | Johnson & Johnson Professionals, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Jan 9, 1998 |
| Received | Oct 30, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974088
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 22, 2012 | Codman & Shurtleff, Inc. Codman ICP Skull Bolt Kit, Product Code: 82-6638. Single Use, disposable drill kit for gaining access to the cranium to allow for insertion and retention of intracranial cranial pressure sensor, inclu Terminated |
GWM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.