The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Hi-torque Balance Trek Guide Wire.
| Device ID | K991152 |
| 510k Number | K991152 |
| Device Name: | HI-TORQUE BALANCE TREK GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Contact | Margaret Anderson |
| Correspondent | Margaret Anderson GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-06 |
| Decision Date | 1999-04-29 |
| Summary: | summary |