510(k) K042359 ยท JXG Shunt, Central Nervous System And Components
SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL
| Applicant | Medical Designs, LLC, Sioux Falls SD, US |
| Decision | Substantially Equivalent, Nov 17, 2004 |
| Received | Aug 31, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042359
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2013 | Integra LifeSciences Corp. d.b.a. Integra Pain Management Integra Cranial Access Kit, Model Number HITHSP10, Rx Only.
Integra Cranial Access Kits (CRAK) allows for burr hole access to the subarachnoid space or the lateral ventricles of the brain. The kit is Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.