RadialSeal Introducer Kit
K-Number: K181855 · 2018-07-26
ApplicantGreat Batch Medical
Decision Date2018-07-26
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
RadialSeal Introducer Kit is a medical device manufactured by Great Batch Medical. It received FDA 510(k) clearance on 2018-07-26 under approval number K181855. 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 RadialSeal Introducer Kit?
RadialSeal Introducer Kit is a medical device that received FDA 510(k) clearance on 2018-07-26. It is manufactured by Great Batch Medical. The 510(k) number is K181855.
When was RadialSeal Introducer Kit approved by the FDA?
RadialSeal Introducer Kit received FDA 510(k) clearance on 2018-07-26, under approval number K181855.
What company makes RadialSeal Introducer Kit?
RadialSeal Introducer Kit is manufactured by Great Batch Medical.
What is the FDA product code for RadialSeal Introducer Kit?
The FDA product code for RadialSeal Introducer Kit 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.