# K092303: Merit Laureate Hydrophilic Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Oct 27, 2009 after 90 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K863138 (1986). 2 ancestors in all.
9 later devices descend from it; 1 cites 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)
- K863138: Terumo Radifocus Guide Wire, Terumo Medical Corp. (1986) Summary page 1.
- K000011: Modified Hydrophilic Coated Guidewire, Lake Region Mfg., Inc. (2000) Summary page 1.

## Most influential descendants
- K120644: Merit Hydrophilic Guide Wire (2012), 8 descendants of its own
- 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

## Recalls of this device
- Jun 28, 2010 · Not classified · Z-2101-2010: Guidewires have decreased lubricity at the proximal end, inhibiting proper operation.
- Jun 28, 2010 · Not classified · Z-2104-2010: Guidewires have decreased lubricity at the proximal end, inhibiting proper operation.
- Jun 28, 2010 · Not classified · Z-2103-2010: Guidewires have decreased lubricity at the proximal end, inhibiting proper operation.
- Jun 28, 2010 · Not classified · Z-2105-2010: Guidewires have decreased lubricity at the proximal end, inhibiting proper operation.
- Jun 28, 2010 · Not classified · Z-2102-2010: Guidewires have decreased lubricity at the proximal end, inhibiting proper operation.
- Jun 28, 2010 · Not classified · Z-2106-2010: Guidewires have decreased lubricity at the proximal end, inhibiting proper operation.

## 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/K092303
Methodology: https://510kreport.com/methodology