# K141933: Filao NC RX Ptca Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Natec Medical, Ltd.
- Decided: Jun 28, 2015 after 347 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- 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 P790017 (1980). 6 ancestors in all.
No later device cites it as a predicate yet.
1 of 7 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112735: Tamarin Blue Ptca RX Dilatation Catheter, Natec Medical, Ltd. (2012) Summary page 4.
- K110134: NC Trek RX Coronary Dilatation Catheter, Abbott Vascular-Cardiac Therapies (2011) Summary page 4.

## Indications for use
The Filao NC RX PTCA Dilatation Catheters are indicated for; Balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis, for the purpose of improving myocardial perfusion. Balloon dilatation of a stent after implantation (balloon models 2.00mm - 4.50mm)

Source page: https://510kreport.com/device/K141933
Methodology: https://510kreport.com/methodology