The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Acs Hi-torque Wholey Supra Core Guide Wire.
| Device ID | K980119 |
| 510k Number | K980119 |
| Device Name: | ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE |
| 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 | 1998-01-13 |
| Decision Date | 1998-03-20 |
| Summary: | summary |