# K130391: Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter, Emerge Over-the-Wire Ptca Dilat

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Jul 10, 2013 after 145 days
- Product code: LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.5100
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to P860019 (1986). 3 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113220: Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca  Dilatation Catheter (Over-the-Wire), Boston Scientific Corporation (2012) Summary page 1.
- K121196: Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire), Boston Scientific Corp (2012) Summary page 1.

## Most influential descendants
- K163174: Emerge PTCA Dilatation Catheter (2016), 2 descendants of its own
- K173680: Sapphire II PRO (2018), 1 descendant of its own
- K233505: Sapphire ULTRA Coronary Dilatation Catheter (2024), 0 descendants of its own
- K223022: SC HONKYTONK PTCA Balloon Dilatation Catheter (2023), 0 descendants of its own
- K220629: Emerge Monorail PTCA Dilatation Catheter (2022), 0 descendants of its own

## Recalls of this device
- Oct 24, 2019 · Class II · Z-0577-2020: Certain dilation and extension catheters are being recalled because these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufact

## Indications for use
The Emerge Over-The-Wire and Emerge Monorail PTCA Dilastation Catheters (1.20 mm balloon models) are Indicated as pro-dilatation catheters in the stenotic portion of a coronary artery or bypass graft stenosis (70% stenosis).

Source page: https://510kreport.com/device/K130391
Methodology: https://510kreport.com/methodology