The following data is part of a premarket notification filed by Guidant Corp. with the FDA for Rx Viatrac 14 Peripheral Dilatation Catheter.
| Device ID | K000101 |
| 510k Number | K000101 |
| Device Name: | RX VIATRAC 14 PERIPHERAL DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Contact | Kobby Dankwah |
| Correspondent | Kobby Dankwah GUIDANT CORP. 3200 LAKESIDE DR. Santa Clara, CA 95054 -2807 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-13 |
| Decision Date | 2000-02-10 |