# K120644: Merit Hydrophilic Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Sep 19, 2012 after 201 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K863138 (1986). 3 ancestors in all.
8 later devices descend from it; 4 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092303: Merit Laureate Hydrophilic Guide Wire, Merit Medical Systems, Inc. (2009) Summary page 1.

## Most influential descendants
- K130588: Merit Hydrophilic Guide Wire (2013), 6 descendants of its own
- K131710: Merit Hydrophilic Guide Wire (2013), 5 descendants of its own
- K123609: Merit Hydrophilic Guide Wire (2013), 5 descendants of its own
- K141295: Merit Hydrophilic Guidewire (2014), 4 descendants of its own
- K170933: Merit Hydrophilic Guide Wire (2017), 3 descendants of its own

## Recalls of this device
- Apr 14, 2014 · Class II · Z-1485-2014: Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft. This lot was par
- Apr 14, 2014 · Class II · Z-1486-2014: Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWS

## Indications for use
The Merit Hydrophilic Guide Wire is intended to facilitate the placement of devices during diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K120644
Methodology: https://510kreport.com/methodology