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FDA 510(k)

Endura guidewire

K-Number: K161702 · 2016-12-06

ApplicantVascular Solutions, Inc.
Decision Date2016-12-06
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Endura guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2016-12-06 under 510(k) number K161702. 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 Endura guidewire?

Endura guidewire is a medical device that received FDA 510(k) clearance on 2016-12-06. The listed applicant is Vascular Solutions, Inc.. The 510(k) number is K161702.

When did Endura guidewire receive FDA 510(k) clearance?

Endura guidewire received FDA 510(k) clearance on 2016-12-06, under 510(k) number K161702.

Who is the listed applicant for Endura guidewire?

The FDA 510(k) record lists Vascular Solutions, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endura guidewire?

The FDA product code for Endura guidewire is DQX.

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Related Devices (Code: DQX)

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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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