The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Retracta Detachable Embolization Coil.
| Device ID | K151676 |
| 510k Number | K151676 |
| Device Name: | Retracta Detachable Embolization Coil |
| Classification | Device, Vascular, For Promoting Embolization |
| Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Contact | David Lehr |
| Correspondent | David Lehr COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
| Product Code | KRD |
| CFR Regulation Number | 870.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-22 |
| Decision Date | 2015-07-22 |
| Summary: | summary |