The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Hilal Embolization Microcoils.
| Device ID | K160219 |
| 510k Number | K160219 |
| Device Name: | Hilal Embolization MicroCoils |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-29 |
| Decision Date | 2016-08-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002475168 | K160219 | 000 |
| 00827002474994 | K160219 | 000 |
| 00827002475007 | K160219 | 000 |
| 00827002475014 | K160219 | 000 |
| 00827002475021 | K160219 | 000 |
| 00827002475038 | K160219 | 000 |
| 00827002475045 | K160219 | 000 |
| 00827002475052 | K160219 | 000 |
| 00827002475069 | K160219 | 000 |
| 00827002475076 | K160219 | 000 |
| 00827002475083 | K160219 | 000 |
| 00827002475090 | K160219 | 000 |
| 00827002475106 | K160219 | 000 |
| 00827002475113 | K160219 | 000 |
| 00827002475120 | K160219 | 000 |
| 00827002475137 | K160219 | 000 |
| 00827002475144 | K160219 | 000 |
| 00827002475151 | K160219 | 000 |
| 00827002474987 | K160219 | 000 |