# K123214: Encore 26 Advantage Kit

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corp
- Decided: Nov 13, 2012 after 29 days
- Product code: MAV (Syringe, Balloon Inflation)
- Device class: 2
- Regulation: 21 CFR 870.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951802 (1995). 2 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120694: Encore 26 Advantage Kit, Boston Scientific Corp (2012) Summary page 1.

## Most influential descendants
- K140673: Insertion Tool (2014), 1 descendant of its own
- K172453: WATCHDOG Hemostasis Valve Kit (2017), 0 descendants of its own
- K140745: Encore 26 Advantage Kit (2014), 0 descendants of its own

## Indications for use
The EncoreTM 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. Individual Device Intended Use: * EncoreTM 26 Inflation Device: Inflation device are indicated for use with balloon dilation catheters to create and monitor pressure in the balloon, and to deflate the balloon. * GateWay TM Plus Y-Adapter: Used for providing hemostasis around guidewires, balloon dilatation catheters, and other therapeutic devices * Torque Device: Used for guidewire manipulation during general intravascular procedures. * Guidewire Insertion Tool: Used for percutaneous introduction and placement of guidewires in vascular procedures.

Source page: https://510kreport.com/device/K123214
Methodology: https://510kreport.com/methodology