HQS Introducer (Model 2064-HQS)
K-Number: K153494 · 2016-08-25
ApplicantAlseal
Decision Date2016-08-25
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
HQS Introducer (Model 2064-HQS) is a medical device manufactured by Alseal. It received FDA 510(k) clearance on 2016-08-25 under approval number K153494. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HQS Introducer (Model 2064-HQS)?
HQS Introducer (Model 2064-HQS) is a medical device that received FDA 510(k) clearance on 2016-08-25. It is manufactured by Alseal. The 510(k) number is K153494.
When was HQS Introducer (Model 2064-HQS) approved by the FDA?
HQS Introducer (Model 2064-HQS) received FDA 510(k) clearance on 2016-08-25, under approval number K153494.
What company makes HQS Introducer (Model 2064-HQS)?
HQS Introducer (Model 2064-HQS) is manufactured by Alseal.
What is the FDA product code for HQS Introducer (Model 2064-HQS)?
The FDA product code for HQS Introducer (Model 2064-HQS) is DYB.
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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.