The following data is part of a premarket notification filed by Micrus Corp. with the FDA for Micrus Modified Microcoil System, Cerecyte.
| Device ID | K033813 |
| 510k Number | K033813 |
| Device Name: | MICRUS MODIFIED MICROCOIL SYSTEM, CERECYTE |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICRUS CORP. 610 PALOMAR AVENUE Sunnyvale, CA 94085 |
| Contact | Margaret Webber |
| Correspondent | Margaret Webber MICRUS CORP. 610 PALOMAR AVENUE Sunnyvale, CA 94085 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-09 |
| Decision Date | 2004-02-04 |
| Summary: | summary |