# K220629: Emerge Monorail PTCA Dilatation Catheter

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific
- Decided: Mar 24, 2022 after 20 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 P860019 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163174: Emerge PTCA Dilatation Catheter, Boston Scientific Corporation (2016) Summary page 4.

## Indications for use
The Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (1.20 mm balloon models) are indicated as pre-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (=70% stenosis). The Emerge Over-The-Wire (balloon models 1.50-4.00 mm) and Emerge Monorail PTCA Dilatation Catheters (balloon models 1.50-5.00 mm) are indicated for the balloon catheter dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Emerge Over-The-Wire (balloon models 2.00-4.00 mm) and Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00-5.00 mm) are also indicated for the postdelivery expansion of balloon expandable stents (bare metal and drug-eluting)

Source page: https://510kreport.com/device/K220629
Methodology: https://510kreport.com/methodology