The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Mreye Embolization Coils.
| Device ID | K150931 |
| 510k Number | K150931 |
| Device Name: | MReye Embolization Coils |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Nozomi Yagi |
| Correspondent | Nozomi Yagi Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-06 |
| Decision Date | 2015-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002203259 | K150931 | 000 |
| 00827002199927 | K150931 | 000 |