ARTLINE
K-Number: K160448 · 2016-07-12
Decision Date2016-07-12
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
ARTLINE is a medical device manufactured by Health Line International Corporation. It received FDA 510(k) clearance on 2016-07-12 under approval number K160448. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ARTLINE?
ARTLINE is a medical device that received FDA 510(k) clearance on 2016-07-12. It is manufactured by Health Line International Corporation. The 510(k) number is K160448.
When was ARTLINE approved by the FDA?
ARTLINE received FDA 510(k) clearance on 2016-07-12, under approval number K160448.
What company makes ARTLINE?
ARTLINE is manufactured by Health Line International Corporation.
What is the FDA product code for ARTLINE?
The FDA product code for ARTLINE is DQY.
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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.