# K253847: Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Ireland, Ltd.
- Decided: Jan 31, 2026 after 60 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: 9 generations back to K863138 (1986). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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), Merit Medical Ireland, Ltd. (2025) Summary page 7.

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

Source page: https://510kreport.com/device/K253847
Methodology: https://510kreport.com/methodology