The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Target Detachable Coils.
| Device ID | K153658 |
| 510k Number | K153658 |
| Device Name: | Target Detachable Coils |
| Classification | Device, Neurovascular Embolization |
| Applicant | Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 -2588 |
| Contact | Kate Taylor |
| Correspondent | Kate Taylor Stryker Neurovascular 47900 Bayside Parkway Fremont, CA 94538 -2588 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-05-19 |
| Summary: | summary |