The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Hi-torque Versaturn Guide Wire.
| Device ID | K141782 |
| 510k Number | K141782 |
| Device Name: | HI-TORQUE VERSATURN GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | Abbott Vascular 3200 LAKESIDE DRIVE Santa Clara, CA 92054 |
| Contact | Vivek Thakkar |
| Correspondent | Vivek Thakkar Abbott Vascular 3200 LAKESIDE DRIVE Santa Clara, CA 92054 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-02 |
| Decision Date | 2014-08-07 |
| Summary: | summary |