# K181023: Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Meril Life Sciences Private Limited
- Decided: May 17, 2018 after 30 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: 5 generations back to P790017 (1980). 10 ancestors in all.
No later device cites it as a predicate yet.
1 of 11 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131169: Mozec - RX Ptca Balloon Dilatation Catheter, Meril Life Sciences Private Limited (2013) Summary page 5.
- K160961: Mozec NC-Rx PTCA Baloon Dilatation Catheter, Meril Life Sciences Private Limited (2016) Summary page 5.

## Indications for use
The Mozec - 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 - Rx PTCA Balloon Dilatation Catheter (balloon models 2.25mm to 4.50mm) is also indicated for post delivery expansion of balloon expandable stents. The Mozec 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 NC - Rx PTCA Balloon Dilatation Catheter is also indicated for post delivery expansion of balloon expandable stents.

Source page: https://510kreport.com/device/K181023
Methodology: https://510kreport.com/methodology