The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Medtronic Ps Medical Strata Nsc Valve And Shunt Assemblies With And Without Bioglide.
| Device ID | K033850 |
| 510k Number | K033850 |
| Device Name: | MEDTRONIC PS MEDICAL STRATA NSC VALVE AND SHUNT ASSEMBLIES WITH AND WITHOUT BIOGLIDE |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DR., Goleta, CA 93117 |
| Contact | Jeffrey Henderson |
| Correspondent | Jeffrey Henderson MEDTRONIC NEUROSURGERY 125 CREMONA DR., Goleta, CA 93117 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-11 |
| Decision Date | 2004-01-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994946461 | K033850 | 000 |
| 00763000029012 | K033850 | 000 |
| 00763000027292 | K033850 | 000 |
| 00643169472938 | K033850 | 000 |
| 00643169472945 | K033850 | 000 |
| 00643169975774 | K033850 | 000 |
| 00643169976054 | K033850 | 000 |
| 00643169976061 | K033850 | 000 |
| 00643169010406 | K033850 | 000 |
| 00763000029005 | K033850 | 000 |