The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Strata Nsc Burr Hole Valve, Model 42335; Shunt Assembly, Model 46635.
| Device ID | K082127 |
| 510k Number | K082127 |
| Device Name: | STRATA NSC BURR HOLE VALVE, MODEL 42335; SHUNT ASSEMBLY, MODEL 46635 |
| Classification | Shunt, Central Nervous System And Components |
| Applicant | MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Contact | Jeffrey Henderson |
| Correspondent | Jeffrey Henderson MEDTRONIC NEUROSURGERY 125 CREMONA DR. Goleta, CA 93117 |
| Product Code | JXG |
| CFR Regulation Number | 882.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-29 |
| Decision Date | 2008-08-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994380128 | K082127 | 000 |
| 00613994380104 | K082127 | 000 |
| 00643169975910 | K082127 | 000 |
| 00643169975781 | K082127 | 000 |
| 00643169840973 | K082127 | 000 |
| 00643169840942 | K082127 | 000 |
| 00763000031220 | K082127 | 000 |
| 00763000031381 | K082127 | 000 |