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FDA 510(k)

ENROUTE 0.014 Guidewire

K-Number: K160643 · 2016-10-18

ApplicantLake Region Medical
Decision Date2016-10-18
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ENROUTE 0.014 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 2016-10-18 under 510(k) number K160643. 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 Guidewire?

ENROUTE 0.014 Guidewire is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Lake Region Medical. The 510(k) number is K160643.

When did ENROUTE 0.014 Guidewire receive FDA 510(k) clearance?

ENROUTE 0.014 Guidewire received FDA 510(k) clearance on 2016-10-18, under 510(k) number K160643.

Who is the listed applicant for ENROUTE 0.014 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 Guidewire?

The FDA product code for ENROUTE 0.014 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.

K253746Enroute 0.014'' Transcarotid GuidewireK242824PTFE GuidewireK221575Pre-Formed BlueK211741Pre-Formed Extra Support Guidewire

Related Devices (Code: DQX)

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.

K253667Accoat Guide WireSp Medical A/SK261640Merit 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.K253746Enroute 0.014'' Transcarotid GuidewireLake Region MedicalK253262EmeryGlide™ (EG18008901)Nano4imaging GmbH

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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