The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Hi-torque Proceed Guide Wire Family.
| Device ID | K201834 |
| 510k Number | K201834 |
| Device Name: | HI-TORQUE PROCEED Guide Wire Family |
| Classification | Wire, Guide, Catheter |
| Applicant | Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95094 |
| Contact | Charlotte Pullman |
| Correspondent | Charlotte Pullman Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95094 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-02 |
| Decision Date | 2020-07-30 |