# K112513: Ebony Pta 0.014 Peripheral Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Natec Medical, Ltd.
- Decided: Dec 9, 2011 after 101 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: 6 generations back to K001134 (2000). 19 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083919: Amphirion Deep 0.014 Otw Pta Balloon Catheter, Invatec Innovative Technologies, S.R.L. (2009) Summary page 1.
- K071189: Cordis Aviator Plus Pta Balloon Dilatation Catheter, Cordis Europa, N.V. (2007) Summary page 1.
- K050389: Ultra-Soft SV Balloon Dilatation Catheter, Boston Scientific Corp (2005) Summary page 1.

## Most influential descendants
- K142459: Ebony PTA 0.014 RX Peripheral Dilatation Catheter (2015), 1 descendant of its own
- K152230: Ebony PTA .014 RX Pheripheral Dilatation Catheter (2015), 0 descendants of its own
- K143041: Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter (2015), 0 descendants of its own

## Indications for use
The Ebony 0.014" PTA Catheter is intended for dilatation of lesions in the iliac, femoral, popliteal, infra popliteal, renal and carotid arteries. This catheter is not for use in coronary or neuro-vasculature.

Source page: https://510kreport.com/device/K112513
Methodology: https://510kreport.com/methodology