The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Stratamr Guider Tool.
| Device ID | K181622 |
| 510k Number | K181622 |
| Device Name: | StrataMR Guider Tool |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Medtronic Neurosurgery 125 Cremona Dr Goleta, CA 93117 |
| Contact | Xiaojian Sun |
| Correspondent | Xiaojian Sun 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 | 2018-06-20 |
| Decision Date | 2018-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000067588 | K181622 | 000 |