# K143036: Ebony PTA 0.035 Peripheral Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Natec Medical, Ltd.
- Decided: Mar 30, 2015 after 159 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: 3 generations back to K042538 (2004). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

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

## Indications for use
The Ebony® PTA .035 Peripheral Dilatation Catheter is intended for dilatation of lesions in the femoral, iliac, popliteal, infrapopliteal & renal arteries. The Ebony® PTA .035°* OTW Peripheral Dilatation Catheter is not for use in the coronary arteries and neuro-vasculature.

Source page: https://510kreport.com/device/K143036
Methodology: https://510kreport.com/methodology