# K143041: Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter

- Pathway: 510(k) (Special)
- Applicant: Natec Medical, Ltd.
- Decided: Jun 4, 2015 after 225 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). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112513: Ebony Pta 0.014 Peripheral Dilatation Catheter, Natec Medical, Ltd. (2011) Summary page 4.
- K103354: Ebony Pta .035 Peripheral Dilatation Catheter, Natec Medical, Ltd. (2011) Summary page 4.

## Indications for use
The Ebony® PTA 0.014" over the wire Catheter is intended for dilatation of lesions in the femoral, popliteal and infrapopliteal arteries. The Ebony® PTA 0.014" over the wire Catheter is contraindicated for use in coronary arteries or neuro-vasculature. The Ebony® PTA 0.018" over the wire Catheter is intended for dilatation of lesions in the femoral, iliac, popliteal, infrapopliteal and renal arteries. The Ebony® PTA 0.018" over the wire Catheter is not for use in coronary arteries or neuro-vasculature.

Source page: https://510kreport.com/device/K143041
Methodology: https://510kreport.com/methodology