# K983055: RX Viatrac 14 Peripheral Dilatation Catheter, Model #'S 1003006-20, 1003007-20, 1003008-20, 1003009-20, 1003010-20, 1003

- Pathway: 510(k) (Traditional)
- Applicant: Guidant Corp.
- Decided: Dec 30, 1998 after 120 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: 1 generation back to K970299 (1997). 2 ancestors in all.
11 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K970299: Jupiter Pta Catheters (Various), Cordis Corp. (1997) 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.

## Most influential descendants
- K012050: Viatrac 14 Plus Peripheral Dilatation Catheter (2001), 7 descendants of its own
- K072798: Viatrac 14 Plus Peripheral Dilation Catheter (2008), 6 descendants of its own
- K102705: Armada 14 Pta Catheter (2010), 4 descendants of its own
- K033875: Atb All-Terrain Balloon Pta Dilatation Catheter (2004), 1 descendant of its own
- K260304: WAVE PTA Balloon Catheter (2026), 0 descendants of its own

## Indications for use
The RX VIATRAC™ 14 Peripheral Dilatation Catheter is indicated for dilatation of stenoses in the peripheral vasculature (iliac, femoral, ilio-femoral, popliteal, infra-popliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. In addition, the RX VIATRAC™ 14 Peripheral Dilatation Catheter is indicated for balloon dilatation of the PALMAZ™ P204 stent following implantation. It is not intended for use in the coronary vasculature.

Source page: https://510kreport.com/device/K983055
Methodology: https://510kreport.com/methodology