VenaOne
K-Number: K200285 · 2020-07-02
ApplicantVena Group, LLC
Decision Date2020-07-02
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
VenaOne is a medical device manufactured by Vena Group, LLC. It received FDA 510(k) clearance on 2020-07-02 under approval number K200285. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the VenaOne?
VenaOne is a medical device that received FDA 510(k) clearance on 2020-07-02. It is manufactured by Vena Group, LLC. The 510(k) number is K200285.
When was VenaOne approved by the FDA?
VenaOne received FDA 510(k) clearance on 2020-07-02, under approval number K200285.
What company makes VenaOne?
VenaOne is manufactured by Vena Group, LLC.
What is the FDA product code for VenaOne?
The FDA product code for VenaOne is JOW.
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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.