The following data is part of a premarket notification filed by Micrus Endovascular Corporation with the FDA for Micrus Modified Microcoil 18-system, Cerecyte, Model Csp & Che.
| Device ID | K053160 |
| 510k Number | K053160 |
| Device Name: | MICRUS MODIFIED MICROCOIL 18-SYSTEM, CERECYTE, MODEL CSP & CHE |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICRUS ENDOVASCULAR CORPORATION 610 PALOMAR AVENUE Sunnyvale, CA 94085 |
| Contact | Margaret Webber |
| Correspondent | Margaret Webber MICRUS ENDOVASCULAR CORPORATION 610 PALOMAR AVENUE Sunnyvale, CA 94085 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-14 |
| Decision Date | 2005-12-07 |
| Summary: | summary |