The following data is part of a premarket notification filed by Micrus Endovascular Corporation with the FDA for Micrus Microcoli System, Deltaplush, Models Cpl, Dpl.
| Device ID | K083646 |
| 510k Number | K083646 |
| Device Name: | MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICRUS ENDOVASCULAR CORPORATION 821 FOX LANE San Jose, CA 95131 |
| Contact | Patrick Lee |
| Correspondent | Patrick Lee MICRUS ENDOVASCULAR CORPORATION 821 FOX LANE San Jose, CA 95131 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-09 |
| Decision Date | 2009-01-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00878528008316 | K083646 | 000 |
| 00878528008170 | K083646 | 000 |
| 00878528008187 | K083646 | 000 |
| 00878528008194 | K083646 | 000 |
| 00878528008200 | K083646 | 000 |
| 00878528008217 | K083646 | 000 |
| 00878528008224 | K083646 | 000 |
| 00878528008231 | K083646 | 000 |
| 00878528008248 | K083646 | 000 |
| 00878528008255 | K083646 | 000 |
| 00878528008262 | K083646 | 000 |
| 00878528008279 | K083646 | 000 |
| 00878528008286 | K083646 | 000 |
| 00878528008293 | K083646 | 000 |
| 00878528008309 | K083646 | 000 |
| 00878528008163 | K083646 | 000 |