The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Hi-torque Balance Guide Wire With Hydrocoat Hydrophilic Coating, Acs Hi-torque Balance Middleweight Guide Wire With Hydg.
| Device ID | K973494 |
| 510k Number | K973494 |
| Device Name: | HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG |
| Classification | Wire, Guide, Catheter |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
| Contact | Margaret Anderson |
| Correspondent | Margaret Anderson GUIDANT CORP. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-15 |
| Decision Date | 1997-12-12 |
| Summary: | summary |