The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Target Detachable Coil.
| Device ID | K113412 |
| 510k Number | K113412 |
| Device Name: | TARGET DETACHABLE COIL |
| Classification | Device, Neurovascular Embolization |
| Applicant | STRYKER NEUROVASCULAR 47900 BAYSIDE PARKWAY Fremont, CA 94538 -6515 |
| Contact | Rhoda Santos |
| Correspondent | Rhoda Santos STRYKER NEUROVASCULAR 47900 BAYSIDE PARKWAY Fremont, CA 94538 -6515 |
| Product Code | HCG |
| CFR Regulation Number | 882.5950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-18 |
| Decision Date | 2011-12-13 |
| Summary: | summary |