# K120119: Sunmed Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Sunny Medical Device (Shenzhen) Co., Ltd.
- Decided: May 11, 2012 after 115 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 K974713 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993000: Bard Hydrophilic Coated Guide Wires, C.R. Bard, Inc. (1999) Summary page 1.
- K082094: Bard Ptfe (Teflon) Coated Guide Wires, C.R. Bard Inc., Bard Electrophysiology Division (2008) Summary page 1.

## Indications for use
Sunmed Guidewires are used for the introduction and placement of diagnostic or interventional devices in the coronary and peripheral vasculature and may be used to reach and cross a target lesion.

Source page: https://510kreport.com/device/K120119
Methodology: https://510kreport.com/methodology