The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Asc Balance Middleweight Guide Wire.
| Device ID | K971815 |
| 510k Number | K971815 |
| Device Name: | ASC BALANCE MIDDLEWEIGHT GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
| Contact | Mona Mirapuri |
| Correspondent | Mona Mirapuri GUIDANT CORP. 3200 LAKESIDE DR. P.O. BOX 58167 Santa Clara, CA 95052 -8167 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-16 |
| Decision Date | 1997-07-09 |
| Summary: | summary |