The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Hi-torque Floppy Guide Wire With Hydrocoat Hydrophilic Coating, Hi-torque Standard Guide Wire With Hydrocoat Hydrophilic.
| Device ID | K974773 |
| 510k Number | K974773 |
| Device Name: | HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILIC |
| 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 | 1997-12-22 |
| Decision Date | 1998-03-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28717648080047 | K974773 | 000 |
| 08717648079955 | K974773 | 000 |
| 28717648079942 | K974773 | 000 |
| 28717648079935 | K974773 | 000 |
| 28717648079911 | K974773 | 000 |
| 28717648079805 | K974773 | 000 |
| 08717648079771 | K974773 | 000 |
| 08717648079757 | K974773 | 000 |
| 28717648079652 | K974773 | 000 |