# K221057: Viatrac 14 Plus Peripheral Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Abbott Vascular
- Decided: May 5, 2022 after 24 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: 7 generations back to K001134 (2000). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072798: Viatrac 14 Plus Peripheral Dilation Catheter, Abbott Vascular-Vascular Solutions (2008) Summary page 4.

## 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) or 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/K221057
Methodology: https://510kreport.com/methodology