# K142051: Prelude Plastic Jacketed Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Dec 17, 2014 after 142 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: 4 generations back to K954234 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
1 of 10 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082644: Glidesheath, Terumo Medical Corp. (2008) Summary page 4.

## Indications for use
The Merit plastic jacketed introducer guide wire is intended to facilitate the placement of devices during diagnostic and interventional procedures, specifically sheath introducers. The wire is indicated for the peripheral vasculature only.

Source page: https://510kreport.com/device/K142051
Methodology: https://510kreport.com/methodology