The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Rx Viatrac 18 Peripheral Dilatation Catheter, Otw Viatrac 18 Peripheral Dilatation Catheter.
| Device ID | K993639 |
| 510k Number | K993639 |
| Device Name: | RX VIATRAC 18 PERIPHERAL DILATATION CATHETER, OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER |
| 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 | 1999-10-28 |
| Decision Date | 2000-01-27 |
| Summary: | summary |