# K120863: Wholey Guide Wire System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Apr 19, 2012 after 28 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: 1 generation back to K861765 (1986). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K861765: Acs Wholey HI-Torque Guide Wire, Advanced Cardiovascular Systems, Inc. (1986) Summary page 1.

## Most influential descendants
- K193571: Go2Wire Guide Wire (2020), 0 descendants of its own

## Indications for use
The Wholey Guide Wire System is intended to facilitate the placement and exchange of interventional devices during diagnostic or therapeutic interventional procedures. The guide wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.

Source page: https://510kreport.com/device/K120863
Methodology: https://510kreport.com/methodology