The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Medtronic Stratavarius.
| Device ID | K041992 |
| 510k Number | K041992 |
| Device Name: | MEDTRONIC STRATAVARIUS |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Contact | Jeff Henderson |
| Correspondent | Jeff Henderson 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 | 2004-07-23 |
| Decision Date | 2005-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169980402 | K041992 | 000 |
| 00763000292546 | K041992 | 000 |
| 00763000351410 | K041992 | 000 |
| 00763000266974 | K041992 | 000 |
| 00763000266981 | K041992 | 000 |
| 00885074204574 | K041992 | 000 |
| 00885074204598 | K041992 | 000 |
| 00885074467795 | K041992 | 000 |
| 00643169373686 | K041992 | 000 |
| 00643169497610 | K041992 | 000 |
| 00643169497627 | K041992 | 000 |
| 00763000292553 | K041992 | 000 |