# K103354: Ebony Pta .035 Peripheral Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Natec Medical, Ltd.
- Decided: Feb 23, 2011 after 99 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: 2 generations back to K042538 (2004). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062809: Admiral Xtreme Pta Catheter, Invatec Innovative Technologies (2006) Summary page 1.

## Most influential descendants
- K143041: Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter (2015), 0 descendants of its own
- K143036: Ebony PTA 0.035 Peripheral Dilatation Catheter (2015), 0 descendants of its own

## Indications for use
The Ebony" .035 PTA Catheter is intended for the dilation of lesions in the femoral, iliac, popliteal, infrapopliteal and renal arteries. The EbonyO .035 PTA Catheter is not for use in coronary arteries or neuro-vasculature.

Source page: https://510kreport.com/device/K103354
Methodology: https://510kreport.com/methodology