Cleared Special

Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5) (K251181) - FDA 510(k) Clearance

Also marketed or referenced as:
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)

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K251181 · Merit Medical Ireland, Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
135d
Days
Class 2
Risk

K251181 is an FDA 510(k) clearance for the Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5). Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Merit Medical Ireland, Ltd. (Galway, IE). The FDA issued a Cleared decision on August 29, 2025 after a review of 135 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Merit Medical Ireland, Ltd. devices

Submission Details

510(k) Number K251181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2025
Decision Date August 29, 2025
Days to Decision 135 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 125d · This submission: 135d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQX Wire, Guide, Catheter

All 251
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