The following data is part of a premarket notification filed by Guidant Corp. with the FDA for 1 Otw Viatrac 18 Peripheral Dilatation Catheter.
| Device ID | K000793 |
| 510k Number | K000793 |
| Device Name: | 1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | GUIDANT CORP. 26531 YNEZ RD. Temecula, CA 92591 -4630 |
| Contact | Byron Lambert |
| Correspondent | Byron Lambert GUIDANT CORP. 26531 YNEZ RD. Temecula, CA 92591 -4630 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-13 |
| Decision Date | 2000-04-12 |