The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Rx Viatrac 14 Peripheral Dilatation Catheter, Model #'s 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003.
| Device ID | K983055 |
| 510k Number | K983055 |
| Device Name: | RX VIATRAC 14 PERIPHERAL DILATATION CATHETER, MODEL #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003 |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Contact | Susan Silavin |
| Correspondent | Susan Silavin GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-01 |
| Decision Date | 1998-12-30 |
| Summary: | summary |