# K160961: Mozec NC-Rx PTCA Baloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Meril Life Sciences Private Limited
- Decided: Jul 30, 2016 after 116 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: 4 generations back to P790017 (1980). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103153: Voyager NC Coronary Dilatation Catheter and NC Trek RX Coronary Dilatation Catheter, Abbott Vascular-Cardiac Therapies (2010) Summary page 5.
- K110133: Empira RX Ptca Dilatation Catheter, Empria NC RX Ptca Dilatation Catheter, Creganna-Tactx Medical (2011) Summary page 5.
- K131169: Mozec - RX Ptca Balloon Dilatation Catheter, Meril Life Sciences Private Limited (2013) Summary page 5.

## Most influential descendants
- K181023: Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter (2018), 0 descendants of its own

## Indications for use
The Mozec(TM) NC - Rx PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Mozec(TM) NC - Rx PTCA Balloon Dilatation Catheter is also indicated for post-delivery expansion of balloon expandable stents.

Source page: https://510kreport.com/device/K160961
Methodology: https://510kreport.com/methodology