# K121196: Emerge Ptca Dilatation Catheter (Monorail) Emerge Ptca Dilatation Catheter (Over-the-Wire)

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Aug 31, 2012 after 134 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: 2 generations back to P860019 (1986). 2 ancestors in all.
8 later devices descend from it; 3 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.
- P860019: Scimed Ptca Dilatation Catheter, Scimed Life Systems, Inc. (1986) Summary page 1.

## Most influential descendants
- K130391: Emerge Monorail Ptca Dilatation Catheter, Emerge Push Monorail Ptca Dilatation Catheter, Emerge Over-the-Wire Ptca Dilat (2013), 7 descendants of its own
- 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

## 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 Dilatation Catheters 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. Emerge Over-The-Wire and Emerge Monorail PTCA Dilatation Catheters (balloon models 2.00 - 4.00 mm) are also indicated for the post-delivery expansion of balloon expandable stents; (bare metal and drug-eluting).

Source page: https://510kreport.com/device/K121196
Methodology: https://510kreport.com/methodology