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 |
00763000422639 | K212641 | 000 |
00763000422622 | K212641 | 000 |