# K113162: Slidewiretm (Trademark Pending)

- Pathway: 510(k) (Traditional)
- Applicant: Acme-Monaco Corp.
- Decided: Jul 20, 2012 after 268 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- 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 K863138 (1986). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K863138: Terumo Radifocus Guide Wire, Terumo Medical Corp. (1986) Summary page 1.
- K063372: Radifocus Glidewire Advantage, Terumo Medical Corp. (2007) Summary page 1.

## Most influential descendants
- K193653: Hydrophilic Coating Guide Wire (2020), 0 descendants of its own

## Indications for use
The Acme Monaco SlidewireTM (Trademark Pending) is intended for use in diagnostic or interventional procedures to assist in directing a catheter to the desired anatomical locations in the coronary or peripheral vasculature.

Source page: https://510kreport.com/device/K113162
Methodology: https://510kreport.com/methodology