The following data is part of a premarket notification filed by Brivant Limited (lake Region Medical) with the FDA for Hi-torque Vektor, .014, 195cm, Str, Hi-torque Vektor, .014, 195cm, J, Hi-torque Vektor, .014, 300cm, Str, Hi-torque Vektor, .014, 300cm, J.
| Device ID | K182457 |
| 510k Number | K182457 |
| Device Name: | Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J |
| Classification | Wire, Guide, Catheter |
| Applicant | Brivant Limited (Lake Region Medical) Parkmore West Business Park Galway, IE H91 Ck22 |
| Contact | Tom J. Healy |
| Correspondent | Tom J. Healy Brivant Limited (Lake Region Medical) Parkmore West Business Park Galway, IE H91 Ck22 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-07 |
| Decision Date | 2019-04-18 |