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FDA 510(k)

Enroute 0.014'' Transcarotid Guidewire

K-Number: K253746 · 2026-03-19

ApplicantLake Region Medical
Decision Date2026-03-19
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Enroute 0.014'' Transcarotid Guidewire is a medical device manufactured by Lake Region Medical. It received FDA 510(k) clearance on 2026-03-19 under approval number K253746. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Enroute 0.014'' Transcarotid Guidewire?

Enroute 0.014'' Transcarotid Guidewire is a medical device that received FDA 510(k) clearance on 2026-03-19. It is manufactured by Lake Region Medical. The 510(k) number is K253746.

When was Enroute 0.014'' Transcarotid Guidewire approved by the FDA?

Enroute 0.014'' Transcarotid Guidewire received FDA 510(k) clearance on 2026-03-19, under approval number K253746.

What company makes Enroute 0.014'' Transcarotid Guidewire?

Enroute 0.014'' Transcarotid Guidewire is manufactured by Lake Region Medical.

What is the FDA product code for Enroute 0.014'' Transcarotid Guidewire?

The FDA product code for Enroute 0.014'' Transcarotid Guidewire is DQX.

Related Clinical Trials

NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT07455747 Real-World Treatment of Extracranial Carotid Artery Disease With the ENROUTE™ Transcarotid Neuroprotection System NOT_YET_RECRUITING

Other Devices by Lake Region Medical

K160643ENROUTE 0.014 Guidewire K211741Pre-Formed Extra Support Guidewire K221575Pre-Formed Blue K242824PTFE Guidewire

Related Devices (Code: DQX)

K160785Worker GuidewireArgon Medical Devices, Inc. K161702Endura guidewireVascular Solutions, Inc. K160594MRWire Guide WireNano4imaging GmbH K160643ENROUTE 0.014 GuidewireLake Region Medical K153685Sunmed Haemostatic ValvesSunny Medical Device (Shenzhen) Co., Ltd. K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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