The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Acs Ht Balance Middleweight Guide Wire.
| Device ID | K983033 |
| 510k Number | K983033 |
| Device Name: | ACS HT BALANCE MIDDLEWEIGHT GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | GUIDANT CORP. 26531 YNEZ RD. P.O. BOX 9018 Temecula, CA 92591 -4628 |
| Contact | Jennifer Pae Riggs |
| Correspondent | Jennifer Pae Riggs GUIDANT CORP. 26531 YNEZ RD. P.O. BOX 9018 Temecula, CA 92591 -4628 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-31 |
| Decision Date | 1998-11-10 |
| Summary: | summary |