The following data is part of a premarket notification filed by Medtronic Neurosurgery with the FDA for Rivulet Ventricular And Snap Shunt And Convertible Ventricular Catheters, Models 41701 And 41704-41715.
| Device ID | K063836 |
| 510k Number | K063836 |
| Device Name: | RIVULET VENTRICULAR AND SNAP SHUNT AND CONVERTIBLE VENTRICULAR CATHETERS, MODELS 41701 AND 41704-41715 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-26 |
| Decision Date | 2007-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994908315 | K063836 | 000 |
| 00763000030889 | K063836 | 000 |
| 00763000030766 | K063836 | 000 |
| 00673978236643 | K063836 | 000 |
| 00643169496781 | K063836 | 000 |
| 00643169497238 | K063836 | 000 |
| 00643169498136 | K063836 | 000 |
| 00643169498174 | K063836 | 000 |
| 00643169498426 | K063836 | 000 |
| 00613994965691 | K063836 | 000 |
| 00613994480446 | K063836 | 000 |
| 00613994908254 | K063836 | 000 |
| 00763000027315 | K063836 | 000 |