The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Viatrac 14 Plus Peripheral Dilatation Catheter.
| Device ID | K012050 |
| 510k Number | K012050 |
| Device Name: | VIATRAC 14 PLUS PERIPHERAL DILATATION CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Contact | Saba Modjarrad |
| Correspondent | Saba Modjarrad GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-02 |
| Decision Date | 2001-09-06 |
| Summary: | summary |