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 a medical device manufactured by Lake Region Medical. It received FDA 510(k) clearance on 2016-10-18 under approval 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. It is manufactured by Lake Region Medical. The 510(k) number is K160643.
When was ENROUTE 0.014 Guidewire approved by the FDA?
ENROUTE 0.014 Guidewire received FDA 510(k) clearance on 2016-10-18, under approval number K160643.
What company makes ENROUTE 0.014 Guidewire?
ENROUTE 0.014 Guidewire is manufactured by Lake Region Medical.
What is the FDA product code for ENROUTE 0.014 Guidewire?
The FDA product code for ENROUTE 0.014 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.