Cleared Special

K253746 - Enroute 0.014'' Transcarotid Guidewire

K253746 is an FDA 510(k) clearance for Enroute 0.014'' Transcarotid Guidewire, manufactured by Lake Region Medical. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Special 510(k) pathway after a 114-day FDA review.

K253746 · Lake Region Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2026
Decision
114d
Days
Class 2
Risk

K253746 is an FDA 510(k) clearance for the Enroute 0.014'' Transcarotid Guidewire. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Lake Region Medical (Galway, IE). The FDA issued a Cleared decision on March 19, 2026 after a review of 114 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.

FDA 510(k) Submission Details - K253746

510(k) Number K253746 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2025
Decision Date March 19, 2026
Days to Decision 114 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
11d faster than avg
Panel avg: 125d · This submission: 114d
Pathway characteristics
Modification to existing cleared device.

DQX Device Classification - Class 2, Special Controls

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 768
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K253746.
Merit MAK Nitinol/Gold-Tungsten Guide Wire
K261640 · Merit Medical Ireland, Ltd. · Jul 2026
InQwire Amplatz Guide Wire
K254137 · Merit Medical Ireland, Ltd. · May 2026
FMD Peripheral Guide Wire F-14 Flex 6
K260544 · FMD Co., Ltd. · Mar 2026
EmeryGlide™ (EG18008901)
K253262 · Nano4imaging GmbH · Mar 2026
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
K253847 · Merit Medical Ireland, Ltd. · Jan 2026
InQwire Super Stiff Guide Wire (IQSS32180J3)
K251385 · Merit Medical Ireland, Ltd. · Jan 2026
K253746 · Enroute 0.014'' Transcarotid Guidewire
Download PDF FDA Summary Lake Region Medical