# K131169: Mozec - RX Ptca Balloon Dilatation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Meril Life Sciences Private Limited
- Decided: Dec 24, 2013 after 244 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). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- P790017: Usci Dilatation Catheter, Medtronic, Ireland (1980) Summary page 2.
- P860019: Scimed Ptca Dilatation Catheter, Scimed Life Systems, Inc. (1986) Summary page 2.
- K112735: Tamarin Blue Ptca RX Dilatation Catheter, Natec Medical, Ltd. (2012) Summary page 2.

## Most influential descendants
- K160961: Mozec NC-Rx PTCA Baloon Dilatation Catheter (2016), 1 descendant of its own
- 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 - 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 - Rx PTCA Balloon Dilatation Catheter (balloon models 2.25mm to 4.50mm) is also indicated for post-delivery expansion of balloon expandable stents.

Source page: https://510kreport.com/device/K131169
Methodology: https://510kreport.com/methodology