Merit Hydrophilic Guide Wire
by Merit Medical Systems, Inc. 6 variants
510(k) K123609
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123609 | Date16 Jan 2013 | StatusActive |
Official records
- FDA 510(k) database K123609
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DQX
- Device class
- Class II
- Regulation
- 21 CFR Part 870.1330
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Merit Hydrophilic Guide Wire is a steerable guide wire designed for use in peripheral vascular interventions. It features a hydrophilic coating to reduce friction and enhance lubricity, aiding in the precise navigation and placement of catheters and other devices within blood vessels during diagnostic and interventional procedures.
This device is supplied sterile and intended for single-use. It is regulated under FDA 510(k) clearance (K123609) as a substantially equivalent cardiovascular device, classified under product code DQX. The hydrophilic coating ensures smooth catheter exchanges and improved visibility, supporting complex procedures in peripheral vascular systems.
From the manufacturer
SplashWire Hydrophilic Steerable Guide Wire TIME TO REIMAGINE YOUR GUIDE WIRE The Merit SplashWire® combines optimum lubricity. exceptional torque response. and enhanced visibility. Helping you achieve the successful outcomes you expect even in the most complex cases.
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.
PDF HYDROPHILIC GUIDE WIRE - cloud.. The Merit Hydrophilic Guide Wire is used to facilitate the placement of devices during diagnostic and interventional procedures.