# K993639: RX Viatrac 18 Peripheral Dilatation Catheter, Otw Viatrac 18 Peripheral Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Jan 27, 2000 after 91 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K970299 (1997). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983055: RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003, Guidant Corp. (1998) Summary page 1.
- K972825: OPTA5 Pta Balloon Catheter, Powerflex Pta Balloon Catheter, Ultra-Thin Diamond Balloon Catheter, Palmaz Balloon Expandab, Cordis Corp. (1997) Summary page 1.

## Indications for use
The RX VIATRAC™ 18 Peripheral Dilatation Catheter is intended: To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries) For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. For post deployment optimization of the 28 mm GUIDANT MEGALINK™ Biliary Stent (6.0 to 10.0 mm diameters). The OTW VIATRAC™ 18 Peripheral Dilatation Catheter is intended: To dilate stenoses in the peripheral arteries (iliac, femoral, ilio-femoral, popliteal, infra popliteal, renal arteries) For the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. For post deployment optimization of the 28 mm GUIDANT MEGALINK™ Biliary Stent (6.0 to 10.0 mm diameters).

Source page: https://510kreport.com/device/K993639
Methodology: https://510kreport.com/methodology