# K141118: Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Ev3, Inc.
- Decided: Jul 18, 2014 after 79 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: 10 generations back to K001134 (2000). 22 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132777: Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation Catheter, Ev3, Inc. (2013) Summary page 1.
- K093286: Powercross .018 Otw Pta Dilation Catheter, Ev3, Inc. (2009) Summary page 1.

## Most influential descendants
- K160256: Polux , Minerva and Atropos PTA Balloon Dilatation Catheter (2016), 1 descendant of its own
- K142459: Ebony PTA 0.014 RX Peripheral Dilatation Catheter (2015), 1 descendant of its own
- K243704: Parafleet SC 014 PTA Balloon Dilatation Catheter; Parafleet SC 018 PTA Balloon Dilatation Catheter; Parafleet SC 035 PTA Balloon Dilatation Catheter (2025), 0 descendants of its own
- K160941: Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter (2016), 0 descendants of its own
- K152230: Ebony PTA .014 RX Pheripheral Dilatation Catheter (2015), 0 descendants of its own

## Recalls of this device
- Dec 10, 2024 · Class II · Z-0904-2025: There is the potential for in-vivo balloon deflation issues, including difficulty or inability to deflate the balloon in specific lots.

## Indications for use
The NanoCross Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter is intended to dilate stenoses in the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature.

Source page: https://510kreport.com/device/K141118
Methodology: https://510kreport.com/methodology