FDA 510(k)

Enroute 0.014'' Transcarotid Guidewire

K-Number: K253746 · 2026-03-19

Decision Date2026-03-19

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Enroute 0.014'' Transcarotid Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Lake Region Medical. It received FDA 510(k) clearance on 2026-03-19 under 510(k) 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. The listed applicant is Lake Region Medical. The 510(k) number is K253746.

When did Enroute 0.014'' Transcarotid Guidewire receive FDA 510(k) clearance?

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

Who is the listed applicant for Enroute 0.014'' Transcarotid Guidewire?

The FDA 510(k) record lists Lake Region Medical as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Lake Region Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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

Related Devices (Code: DQX)

K253667Accoat Guide WireSp Medical A/S K261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.K253262EmeryGlide™ (EG18008901)Nano4imaging GmbH K253847Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)Merit Medical Ireland, Ltd.

Official Source

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