The following data is part of a premarket notification filed by Micrus Endovascular Corporation with the FDA for Micrus Microcoil System, Deltapaq 10 Stretch Resistant.
| Device ID | K080379 |
| 510k Number | K080379 |
| Device Name: | MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-13 |
| Decision Date | 2008-06-30 |
| Summary: | summary |