The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Hi-torque Steelcore 18 Guide Wire Model Numbers 1003280, 1003281, 1003282.
| Device ID | K982876 |
| 510k Number | K982876 |
| Device Name: | HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282 |
| Classification | Wire, Guide, Catheter |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Contact | Susan Silavin |
| Correspondent | Susan Silavin GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-14 |
| Decision Date | 1998-11-10 |
| Summary: | summary |