510(k) K102875 ยท GWM Device, Monitoring, Intracranial Pressure
CAMINO 110-4B OLM INTRACRANIAL PRESSURE MNITORING KIT; CAMINO 110-4G POST CRANIOTOMY SUBDURAL PRESSURE MONITORING KIT; C
| Applicant | Integra LifeSciences Corporation, Planisboro NJ, US |
| Decision | Substantially Equivalent, Dec 20, 2010 |
| Received | Oct 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K102875
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2015 | Integra LifeSciences Corp. Integra Camino Intracranial Pressure Monitoring Catheter with Licox IMC Bolt Fitting, Catalog No. 110-4L
The Camino Intracranial Pressure Monitoring Catheter is a sterile transducer-tipped pressure mo Terminated |
GWM | None listed |
| Jul 17, 2014 | Integra LifeSciences Corp. Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters,
Cat. No's. 110-4B, 110-4G, 110-4H, 110-4L Terminated |
GWN | None listed |
| Oct 30, 2013 | Integra Limited Brand Names: Integra Camino 110-4 Intracranial Pressure (ICP) Monitoring
Catheters.
Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC.
The fully packaged 110-4B, 110- Terminated |
GWM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.