510(k) K172022 ยท JXG Shunt, Central Nervous System And Components
CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled)
| Applicant | Codman & Shurtleff, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Oct 3, 2017 |
| Received | Jul 5, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172022
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 14, 2020 | Integra LifeSciences Corp. Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage: use in the treatment of hydrocephalus as a component of a shunt system when draining or shunting cerebrospinal fluid (CSF)
Terminated |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.