The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Hi-torque Command 18 Guide Wire.
| Device ID | K152404 |
| 510k Number | K152404 |
| Device Name: | Hi-Torque Command 18 Guide Wire |
| Classification | Wire, Guide, Catheter |
| Applicant | ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
| Contact | Shu Chi Hsu |
| Correspondent | Shu Chi Hsu ABBOTT VASCULAR 3200 Lakeside Drive Santa Clara, CA 95054 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-25 |
| Decision Date | 2015-09-21 |
| Summary: | summary |