The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Medtronic Strata Nsc Lumboperitoneal Valve And Shunt System.
| Device ID | K123524 |
| 510k Number | K123524 |
| Device Name: | MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Contact | Donovan May |
| Correspondent | Donovan May MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-15 |
| Decision Date | 2013-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994653352 | K123524 | 000 |
| 00763000027179 | K123524 | 000 |
| 00763000027513 | K123524 | 000 |
| 00763000027520 | K123524 | 000 |
| 00763000027537 | K123524 | 000 |
| 00763000027773 | K123524 | 000 |
| 00643169466210 | K123524 | 000 |
| 00643169975842 | K123524 | 000 |
| 00643169975859 | K123524 | 000 |
| 00643169975866 | K123524 | 000 |
| 00643169975873 | K123524 | 000 |
| 00643169975880 | K123524 | 000 |
| 00643169975897 | K123524 | 000 |
| 00643169010765 | K123524 | 000 |
| 00643169010772 | K123524 | 000 |
| 00643169010789 | K123524 | 000 |
| 00643169010796 | K123524 | 000 |
| 00613994653345 | K123524 | 000 |
| 00763000027162 | K123524 | 000 |