The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Stratamr Valves And Shunts.
| Device ID | K152700 |
| 510k Number | K152700 |
| Device Name: | StrataMR Valves And Shunts |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DRIVE Goleta, CA 93117 |
| Contact | Micah Schloss |
| Correspondent | Deep Pal MEDTRONIC NEUROSURGERY 125 CREMONA DRIVE 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 | 2015-09-21 |
| Decision Date | 2016-04-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169692886 | K152700 | 000 |
| 00643169692718 | K152700 | 000 |
| 00643169692701 | K152700 | 000 |
| 00643169616486 | K152700 | 000 |
| 00643169616479 | K152700 | 000 |
| 00643169616462 | K152700 | 000 |
| 00643169616455 | K152700 | 000 |
| 00643169593442 | K152700 | 000 |
| 00643169593435 | K152700 | 000 |