The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Hi-toque Whisper Ls And Ms Guide Wire With Hydrocoat Hydrophilic Coating.
| Device ID | K013092 |
| 510k Number | K013092 |
| Device Name: | HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING |
| Classification | Wire, Guide, Catheter |
| Applicant | GUIDANT CORP. 26531 YNEZ RD. Temecula, CA 92591 -4630 |
| Contact | Jennifer P Riggs |
| Correspondent | Jennifer P Riggs GUIDANT CORP. 26531 YNEZ RD. Temecula, CA 92591 -4630 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-17 |
| Decision Date | 2001-12-13 |
| Summary: | summary |