The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Hi-torque Whisper View Guide Wire.
| Device ID | K061453 |
| 510k Number | K061453 |
| Device Name: | HI-TORQUE WHISPER VIEW GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | GUIDANT CORP. 4100 Hamline Avenue North St. Paul, MN 55112 -5798 |
| Contact | Kathleen Vittum |
| Correspondent | Kathleen Vittum GUIDANT CORP. 4100 Hamline Avenue North St. Paul, MN 55112 -5798 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-25 |
| Decision Date | 2006-06-22 |
| Summary: | summary |