The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Hi-torque Balance, Balance Middleweight, Balance Heavyweight, Balance Trek And The Balance Middleweight Universal Guide.
| Device ID | K021228 |
| 510k Number | K021228 |
| Device Name: | HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-18 |
| Decision Date | 2002-05-15 |
| Summary: | summary |