Elite HV Radial
K-Number: K173287 · 2017-12-21
ApplicantGalt Medical Corp.
Decision Date2017-12-21
Product CodeDYB
Advisory CommitteeCV
DecisionUnknown
Device Summary
Elite HV Radial is a medical device manufactured by Galt Medical Corp.. It received FDA 510(k) clearance on 2017-12-21 under approval number K173287. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Unknown.
Frequently Asked Questions
What is the Elite HV Radial?
Elite HV Radial is a medical device that received FDA 510(k) clearance on 2017-12-21. It is manufactured by Galt Medical Corp.. The 510(k) number is K173287.
When was Elite HV Radial approved by the FDA?
Elite HV Radial received FDA 510(k) clearance on 2017-12-21, under approval number K173287.
What company makes Elite HV Radial?
Elite HV Radial is manufactured by Galt Medical Corp..
What is the FDA product code for Elite HV Radial?
The FDA product code for Elite HV Radial 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.