The following data is part of a premarket notification filed by Guidant Corporation with the FDA for Hi-torque Advance And Advance Lite Guide Wire.
| Device ID | K060449 |
| 510k Number | K060449 |
| Device Name: | HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | GUIDANT CORPORATION 26531 YNEZ ROAD Temecula, CA 92591 |
| Contact | Jennifer Pae Riggs |
| Correspondent | Jennifer Pae Riggs GUIDANT CORPORATION 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 | 2006-02-21 |
| Decision Date | 2006-05-30 |
| Summary: | summary |