Kodiak Dual Port Coaxial Introducer Kit
K-Number: K230631 · 2023-05-22
ApplicantArgon Medical Devices
Decision Date2023-05-22
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Kodiak Dual Port Coaxial Introducer Kit is a medical device manufactured by Argon Medical Devices. It received FDA 510(k) clearance on 2023-05-22 under approval number K230631. 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 Kodiak Dual Port Coaxial Introducer Kit?
Kodiak Dual Port Coaxial Introducer Kit is a medical device that received FDA 510(k) clearance on 2023-05-22. It is manufactured by Argon Medical Devices. The 510(k) number is K230631.
When was Kodiak Dual Port Coaxial Introducer Kit approved by the FDA?
Kodiak Dual Port Coaxial Introducer Kit received FDA 510(k) clearance on 2023-05-22, under approval number K230631.
What company makes Kodiak Dual Port Coaxial Introducer Kit?
Kodiak Dual Port Coaxial Introducer Kit is manufactured by Argon Medical Devices.
What is the FDA product code for Kodiak Dual Port Coaxial Introducer Kit?
The FDA product code for Kodiak Dual Port Coaxial 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.