The following data is part of a premarket notification filed by Micrus Endovascular Corporation with the FDA for Micrus Microcoil System, Deltapaq 10 Cerecyte, Model Cdf.
| Device ID | K080437 |
| 510k Number | K080437 |
| Device Name: | MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF |
| 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 | 2008-02-15 |
| Decision Date | 2008-05-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00878528007494 | K080437 | 000 |
| 00878528007166 | K080437 | 000 |
| 00878528007159 | K080437 | 000 |
| 00878528007142 | K080437 | 000 |
| 00878528007135 | K080437 | 000 |
| 00878528007128 | K080437 | 000 |
| 00878528007111 | K080437 | 000 |
| 00878528007104 | K080437 | 000 |
| 00878528007098 | K080437 | 000 |
| 00878528007081 | K080437 | 000 |
| 00878528007074 | K080437 | 000 |
| 00878528007067 | K080437 | 000 |
| 00878528007043 | K080437 | 000 |
| 00878528007036 | K080437 | 000 |
| 00878528007180 | K080437 | 000 |
| 00878528007197 | K080437 | 000 |
| 00878528007463 | K080437 | 000 |
| 00878528007432 | K080437 | 000 |
| 00878528007395 | K080437 | 000 |
| 00878528007388 | K080437 | 000 |
| 00878528007357 | K080437 | 000 |
| 00878528007340 | K080437 | 000 |
| 00878528007302 | K080437 | 000 |
| 00878528007296 | K080437 | 000 |
| 00878528007265 | K080437 | 000 |
| 00878528007258 | K080437 | 000 |
| 00878528007241 | K080437 | 000 |
| 00878528007210 | K080437 | 000 |
| 00878528007203 | K080437 | 000 |
| 00878528007012 | K080437 | 000 |