The following data is part of a premarket notification filed by Stryker Neurovascular with the FDA for Target Detachable Coil.
| Device ID | K123377 |
| 510k Number | K123377 |
| 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 | 2012-11-01 |
| Decision Date | 2012-11-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07613327128390 | K123377 | 000 |
| 04546540711670 | K123377 | 000 |
| 04546540711687 | K123377 | 000 |
| 07613252516439 | K123377 | 000 |
| 07613252516453 | K123377 | 000 |
| 07613327004823 | K123377 | 000 |
| 07613327004830 | K123377 | 000 |
| 07613327128260 | K123377 | 000 |
| 07613327128277 | K123377 | 000 |
| 07613327128284 | K123377 | 000 |
| 07613327128291 | K123377 | 000 |
| 07613327128314 | K123377 | 000 |
| 07613327128321 | K123377 | 000 |
| 07613327128338 | K123377 | 000 |
| 04546540711656 | K123377 | 000 |