# K201595: Merit Hydrophilic Guide Wire

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Oct 14, 2020 after 124 days
- Product code: DQX (Wire, Guide, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1330
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K863138 (1986). 9 ancestors in all.
2 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)
- K170933: Merit Hydrophilic Guide Wire, Merit Medical Systems, Inc. (2017) Summary page 4.

## Most influential descendants
- 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) (2025), 1 descendant of its own
- K253847: Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (2026), 0 descendants of its own

## Recalls of this device
- May 8, 2026 · Class II · Z-2517-2026: Due to unsealed portions of pouches.

## Indications for use
Intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.

Source page: https://510kreport.com/device/K201595
Methodology: https://510kreport.com/methodology