# K072798: Viatrac 14 Plus Peripheral Dilation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Vascular-Vascular Solutions
- Decided: Jan 31, 2008 after 122 days
- Product code: LIT (Catheter, Angioplasty, Peripheral, Transluminal)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K001134 (2000). 18 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012050: Viatrac 14 Plus Peripheral Dilatation Catheter, Guidant Corp. (2001) Summary page 1.
- K053118: Sterling Monorail Pta Balloon Dilatation Catheter, Model H74939031-Xxxxxx, Boston Scientific Corp (2005) Summary page 1.
- K071189: Cordis Aviator Plus Pta Balloon Dilatation Catheter, Cordis Europa, N.V. (2007) Summary page 1.

## Most influential descendants
- 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
- K151317: Armada 18 PTA Catheter (2015), 0 descendants of its own

## Recalls of this device
- May 6, 2009 · Not classified · Z-1178-2010: Abbott Vascular is initiating a recall on the Viatrac 14 Plus 5.0x15 mm Peripheral Dilation Catheter due to a mistake in labeling/packaging.

## 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, renal arteries, and carotid arties) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for post-dilatation of balloon-expandable and self-expanding stents in the peripheral vasculature.

Source page: https://510kreport.com/device/K072798
Methodology: https://510kreport.com/methodology