The following data is part of a premarket notification filed by Abbott Vascular Inc. with the FDA for Hi-torque Jet Guide Wire Family.
| Device ID | K142415 |
| 510k Number | K142415 |
| Device Name: | Hi-Torque JET Guide Wire Family |
| Classification | Wire, Guide, Catheter |
| Applicant | ABBOTT VASCULAR INC. 26531 YNEZ ROAD Temecula, CA 92591 |
| Contact | Janet Benson |
| Correspondent | Janet Benson ABBOTT VASCULAR INC. 26531 YNEZ ROAD Temecula, CA 92591 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-28 |
| Decision Date | 2014-12-19 |
| Summary: | summary |