The following data is part of a premarket notification filed by Micrus Corp. with the FDA for Micrus Microcoil Systems, Models Hel, Sph, Str, Fsr And Hsr.
| Device ID | K031578 |
| 510k Number | K031578 |
| Device Name: | MICRUS MICROCOIL SYSTEMS, MODELS HEL, SPH, STR, FSR AND HSR |
| Classification | Device, Neurovascular Embolization |
| Applicant | MICRUS CORP. 610 PALOMAR AVENUE Mountain View, CA 94085 |
| Contact | Margaret Webber |
| Correspondent | Margaret Webber MICRUS CORP. 610 PALOMAR AVENUE Mountain View, 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 | 2003-05-20 |
| Decision Date | 2003-08-01 |
| Summary: | summary |