# K012050: Viatrac 14 Plus Peripheral Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Guidant Corp.
- Decided: Sep 6, 2001 after 66 days
- Product code: DQY (Catheter, Percutaneous)
- 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). 4 ancestors in all.
7 later devices descend from it; 1 cites it directly.
0 of 12 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.
- K000101: RX Viatrac 14 Peripheral Dilatation Catheter, Guidant Corp. (2000) Summary page 1.

## Most influential descendants
- K072798: Viatrac 14 Plus Peripheral Dilation Catheter (2008), 6 descendants of its own
- K102705: Armada 14 Pta Catheter (2010), 4 descendants of its own
- K260304: WAVE PTA Balloon Catheter (2026), 0 descendants of its own
- K252512: Armada™ 14 NC PTA Catheter (2026), 0 descendants of its own
- K221057: Viatrac 14 Plus Peripheral Dilatation Catheter (2022), 0 descendants of its own

## Indications for use
The VIATRAC™ 14 PLUS Peripheral Dilatation Catheter is indicated to dilate stenosis 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.

Source page: https://510kreport.com/device/K012050
Methodology: https://510kreport.com/methodology