510(k) K831678 ยท JXG Shunt, Central Nervous System And Components
P-S MEDICAL CSF-FLOW CONTROL VALVE-BUR
| Applicant | Pudenz-Schulte Medical Research Corp., Walker MI, US |
| Decision | Substantially Equivalent, Jun 24, 1983 |
| Received | May 23, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K831678
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2021 | Medtronic Neurosurgery Medtronic PS Medical Cerebro Spinal Fluid (CSF)-Flow Control Valves for the following CFNs:
22011 L- SHUNT 22011 L INTL ONLY ULTRA SM LOW
22011 LL - SHUNT 22011 LL INTL ONLY ULTRA SM L-L
22011 M - Open, Classified |
JXG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.