# K141707: Ultraskin Hydrophilic Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Lepu Medical Technology (Beijing) Co., Ltd.
- Decided: Jan 21, 2015 after 211 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.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063372: Radifocus Glidewire Advantage, Terumo Medical Corp. (2007) Summary page 4.

## Indications for use
The ULTRASKINTM Hydrophilic Guide Wire is indicated to direct a catheter to the desired peripheral or coronary anatomical location during diagnostic or interventional procedure.

Source page: https://510kreport.com/device/K141707
Methodology: https://510kreport.com/methodology