The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Hi-torque Balance Iniversal Guide Wire With Hydrocoat Hydrophilic Coating.
| Device ID | K031678 |
| 510k Number | K031678 |
| Device Name: | HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING |
| Classification | Wire, Guide, Catheter |
| Applicant | GUIDANT CORP. 26531 YNEZ RD. Temecula, CA 92591 |
| Contact | Bruce Cerwin |
| Correspondent | Bruce Cerwin GUIDANT CORP. 26531 YNEZ RD. Temecula, CA 92591 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-30 |
| Decision Date | 2003-08-26 |
| Summary: | summary |