# K152230: Ebony PTA .014 RX Pheripheral Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Natec Medical
- Decided: Sep 3, 2015 after 27 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: 12 generations back to K001134 (2000). 38 ancestors in all.
No later device cites it as a predicate yet.
0 of 39 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.
- K142459: Ebony PTA 0.014 RX Peripheral Dilatation Catheter, Natec Medical, Ltd. (2015) Summary page 4.

## Recalls of this device
- Feb 11, 2016 · Class II · Z-1362-2016: Product may kink during use rendering the product unusable.

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

Source page: https://510kreport.com/device/K152230
Methodology: https://510kreport.com/methodology