The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Stratamr Ii Valves And Shunts.
| Device ID | K212641 |
| 510k Number | K212641 |
| Device Name: | StrataMR II Valves And Shunts |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | Medtronic Neurosurgery 5290 California Avenue Irvine, CA 92617 |
| Contact | Swara Vashi |
| Correspondent | Sudeep Nambiar Medtronic Neurosurgery 5290 California Avenue Irvine, CA 92617 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-20 |
| Decision Date | 2021-09-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00763000067571 | K212641 | 000 |
| 00763000422714 | K212641 | 000 |
| 00763000422707 | K212641 | 000 |