The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Target Detachable Coils.
| Device ID | K161429 |
| 510k Number | K161429 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-23 |
| Decision Date | 2016-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327128413 | K161429 | 000 |
| 07613327466386 | K161429 | 000 |
| 07613327466393 | K161429 | 000 |
| 07613327466409 | K161429 | 000 |
| 07613327466416 | K161429 | 000 |
| 07613327466423 | K161429 | 000 |
| 07613327128307 | K161429 | 000 |
| 07613327128345 | K161429 | 000 |
| 07613327128352 | K161429 | 000 |
| 07613327128369 | K161429 | 000 |
| 07613327128376 | K161429 | 000 |
| 07613327128383 | K161429 | 000 |
| 07613327128406 | K161429 | 000 |
| 07613327466379 | K161429 | 000 |