The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Acs Hi-torque Super Sport Guide Wire With Hydrocoat Hydrophilic Coating.
| Device ID | K980294 |
| 510k Number | K980294 |
| Device Name: | ACS HI-TORQUE SUPER SPORT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING |
| Classification | Wire, Guide, Catheter |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Contact | David Kolesar |
| Correspondent | David Kolesar 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 | 1998-01-27 |
| Decision Date | 1998-04-24 |
| Summary: | summary |