# K241521: Prelude Small O.D. Introducer Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Dec 10, 2024 after 195 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 K770977 (1977). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K770977: Cardiovascular Spring Guides, Lake Region Mfg., Inc. (1977) Summary page 5.

## Indications for use
The Prelude Small O.D. Introducer Guide Wire is intended to facilitate the placement of introducer sheaths during diagnostic and interventional procedures. The Prelude Small O.D. Introducer Guide Wire is indicated for use in the peripheral vasculature only.

Source page: https://510kreport.com/device/K241521
Methodology: https://510kreport.com/methodology