The following data is part of a premarket notification filed by Micrus Endovascular Corporation with the FDA for Micrus Microcoil Delivery System, Models Sph, Hel, Che, Pc4, Hsr, Fsr, Csp, Cfs, Src, Pp4, Str.
| Device ID | K071246 |
| 510k Number | K071246 |
| Device Name: | MICRUS MICROCOIL DELIVERY SYSTEM, MODELS SPH, HEL, CHE, PC4, HSR, FSR, CSP, CFS, SRC, PP4, STR |
| 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 | 2007-05-03 |
| Decision Date | 2007-06-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00878528000051 | K071246 | 000 |
| 10886704080428 | K071246 | 000 |