K091312 is an FDA 510(k) clearance for the PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM. This device is classified as a Shunt, Central Nervous System And Components (Class II - Special Controls, product code JXG).
Submitted by Medtronic Neurosurgery (Goleta, US). The FDA issued a Cleared decision on September 2, 2009, 121 days after receiving the submission on May 4, 2009.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5550.
| 510(k) Number | K091312 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2009 |
| Decision Date | September 02, 2009 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | JXG — Shunt, Central Nervous System And Components |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5550 |