The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Mreye Flipper Detachable Embolization Coil And Delivery System.
| Device ID | K150964 |
| 510k Number | K150964 |
| Device Name: | MReye Flipper Detachable Embolization Coil And Delivery System |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47402 |
| Contact | Nozomi Yagi |
| Correspondent | Nozomi Yagi Cook Incorporated 750 Daniels Way Bloomington, IN 47402 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-10 |
| Decision Date | 2015-12-18 |
| Summary: | summary |