The following data is part of a premarket notification filed by Micrus Endovascular Corporation with the FDA for Micrus Microcatheter Courier Pre-shaped, Models Mps170045-00, Mps170090-00, Mps190045-00, Mps190090-00.
| Device ID | K061963 |
| 510k Number | K061963 |
| Device Name: | MICRUS MICROCATHETER COURIER PRE-SHAPED, MODELS MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00 |
| Classification | Catheter, Intravascular, Diagnostic |
| 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 | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-12 |
| Decision Date | 2006-08-04 |
| Summary: | summary |