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 a medical device manufactured by Vascular Solutions, Inc.. It received FDA 510(k) clearance on 2016-12-06 under approval 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. It is manufactured by Vascular Solutions, Inc.. The 510(k) number is K161702.
When was Endura guidewire approved by the FDA?
Endura guidewire received FDA 510(k) clearance on 2016-12-06, under approval number K161702.
What company makes Endura guidewire?
Endura guidewire is manufactured by Vascular Solutions, Inc..
What is the FDA product code for Endura guidewire?
The FDA product code for Endura guidewire is 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.