The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Acs Hi-torque Balance Heavyweight Guide Wire With Hydrocoat Hydrophilic Coating.
| Device ID | K982083 |
| 510k Number | K982083 |
| Device Name: | ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING |
| Classification | Wire, Guide, Catheter |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Contact | Lorna Tsuda |
| Correspondent | Lorna Tsuda 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 | 1998-06-15 |
| Decision Date | 1998-09-11 |
| Summary: | summary |