# K251181: Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guide Wire (MSWSTD35260J1O5); Splashwire Hydrophilic Guide Wire (MSWSTDA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35260LT); Splashwire Hydrophilic Guide Wire (MSWSTFA35150LT); Splashwire Hydrophilic Guide Wire (MSWSTFS38150LT)

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Ireland, Ltd.
- Decided: Aug 29, 2025 after 135 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: 8 generations back to K863138 (1986). 10 ancestors in all.
1 later device descends 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)
- K201595: Merit Hydrophilic Guide Wire, Merit Medical Systems, Inc. (2020) Summary page 6.

## Most influential descendants
- K253847: Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (2026), 0 descendants of its own

## Indications for use
The Merit Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures. These guide wires are not intended for Percutaneous Transluminal Coronary Angioplasty use or for use in the neurovasculature.

Source page: https://510kreport.com/device/K251181
Methodology: https://510kreport.com/methodology