K012052 is an FDA 510(k) clearance for the MEDTRONIC PS MEDICAL STRATA VALVE, MODELS 42855, 42865, 92865, 92855. This device is classified as a Shunt, Central Nervous System And Components (Class II - Special Controls, product code JXG).
Submitted by Medtronic PS Medical (Goleta, US). The FDA issued a Cleared decision on February 11, 2002, 224 days after receiving the submission on July 2, 2001.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5550.
| 510(k) Number | K012052 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2001 |
| Decision Date | February 11, 2002 |
| Days to Decision | 224 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 |