The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Standard 0.025 Straight, Standard 0.025 Angled, Standard 0.032 Straight, Standard 0.032 Angled, Soft 0.035 Straight, Sof.
| Device ID | K983346 |
| 510k Number | K983346 |
| Device Name: | STANDARD 0.025 STRAIGHT, STANDARD 0.025 ANGLED, STANDARD 0.032 STRAIGHT, STANDARD 0.032 ANGLED, SOFT 0.035 STRAIGHT, SOF |
| 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 | 1998-09-23 |
| Decision Date | 1999-03-23 |
| Summary: | summary |