The following data is part of a premarket notification filed by Voyager Therapeutics, Inc. with the FDA for Voyager Trajectory Array Guide (v-tag).
| Device ID | K180854 |
| 510k Number | K180854 |
| Device Name: | Voyager Trajectory Array Guide (V-TAG) |
| Classification | Neurological Stereotaxic Instrument |
| Applicant | Voyager Therapeutics, Inc. 75 Sidney Street Cambridge, MA 02139 |
| Contact | Lynn E Bayless |
| Correspondent | Lynn E Bayless Voyager Therapeutics, Inc. 75 Sidney Street Cambridge, MA 02139 |
| Product Code | HAW |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-02 |
| Decision Date | 2018-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08503590070733 | K180854 | 000 |
| 00850359007737 | K180854 | 000 |