The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Hi-torque Whisper Ls; Hi-torque Whisper Ms; Hi-torque Whisper Ms Cs-j; Hi-torque Whisper Es; Hi-torque Whisper Es Cs-j.
| Device ID | K023300 |
| 510k Number | K023300 |
| Device Name: | HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J |
| Classification | Wire, Guide, Catheter |
| Applicant | GUIDANT CORP. 4100 HAMLINE AVE., NORTH St. Paul, MN 55112 -5798 |
| Contact | Janell A Colley |
| Correspondent | Janell A Colley GUIDANT CORP. 4100 HAMLINE AVE., 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 | 2002-10-03 |
| Decision Date | 2002-10-28 |
| Summary: | summary |