The following data is part of a premarket notification filed by Vesatek, Llc with the FDA for Firebow Wire Torque Assist Device.
| Device ID | K170684 |
| 510k Number | K170684 |
| Device Name: | Firebow Wire Torque Assist Device |
| Classification | Wire, Guide, Catheter |
| Applicant | Vesatek, LLC 17171 Daimler Street Irvine, CA 92614 |
| Contact | David Look |
| Correspondent | Paul Gasser Paul Gasser 13612 Rushmore Lane Santa Ana, CA 92705 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-07 |
| Decision Date | 2017-06-29 |
| Summary: | summary |