# K140745: Encore 26 Advantage Kit

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Apr 17, 2014 after 23 days
- Product code: MAV (Syringe, Balloon Inflation)
- Device class: 2
- Regulation: 21 CFR 870.1650
- 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 K951802 (1995). 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)
- K123214: Encore 26 Advantage Kit, Boston Scientific Corp (2012) Summary page 1.
- K922410: Scimed Avenue Coronary Guidewire Insertion Tool, Scimed Life Systems, Inc. (1992) Summary page 1.

## Recalls of this device
- Aug 5, 2025 · Class II · Z-2534-2025: The Encore 26 Inflation Device is used with balloon dilation catheters to create and monitor pressure in the balloon and to deflate the balloon. An internal investigation determined that during use, f

## Indications for use
The Encore 26 Advantage Kit is a kit of sterile disposable devices intended for use as accessories for percutaneous coronary angiography (PTCA) procedures. They allow for balloon inflation and wire control. *Encore 26 Inflation Device: indicated for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon. *Gateway Plus Y-Adaptor: used for providing hemostasis around balloon dilatation catheters, guidewires and other therapeutic devices during general intravascular procedures. *Torque Device: used for guidewire manipulation during general intravascular procedures. *Insertion Tool: used to facilitate the introduction of a guidewire during general intravascular procedures.

Source page: https://510kreport.com/device/K140745
Methodology: https://510kreport.com/methodology