The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Hi-toque Balance Middleweight Universal Guide Wire With Hydrocoat Hydrophilic Coating, #1009659,1009659j, 1009660, 10096.
| Device ID | K013833 |
| 510k Number | K013833 |
| Device Name: | HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096 |
| Classification | Wire, Guide, Catheter |
| Applicant | GUIDANT CORP. 26531 YNEZ RD. Temecula, CA 92591 -4630 |
| Contact | Jennifer Pae Riggs |
| Correspondent | Jennifer Pae 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 | 2001-11-19 |
| Decision Date | 2002-01-16 |
| Summary: | summary |