# K223189: Firefighter™ NC Pro PTCA Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai MicroPort Medical (Group) Co., Ltd.
- Decided: Jul 21, 2023 after 282 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 P860019 (1986). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141236: NC Emerge Ptca Dilatation Catheter (Monorail), NC Emerge Ptca Dilatation Catheter (Over-the-Wire), Boston Scientific Corporation (2014) Summary page 4.

## Indications for use
Firefighter™ NC Pro PTCA Balloon Catheter is indicated to be used for: • Balloon dilatation of the stenotic portion of a native coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion; • Balloon dilatation of post-delivery expansion of balloon expandable stents (models 2.00-5.00mm).

Source page: https://510kreport.com/device/K223189
Methodology: https://510kreport.com/methodology