The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Hi-torque Whisper Ls Guide Wire With Hydrocoat Hydrophilic Coating, Hi-torque Whisper Ms Guide Wire With Hydrocoat Hydro.
| Device ID | K002206 |
| 510k Number | K002206 |
| Device Name: | HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO |
| Classification | Wire, Guide, Catheter |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Contact | Margaret Anderson |
| Correspondent | Margaret Anderson 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 | 2000-07-21 |
| Decision Date | 2000-08-24 |