Introducer Sheath Kits
K-Number: K222184 · 2023-02-21
Decision Date2023-02-21
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Introducer Sheath Kits is a medical device manufactured by Beijing Demax Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-02-21 under approval number K222184. 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 Introducer Sheath Kits?
Introducer Sheath Kits is a medical device that received FDA 510(k) clearance on 2023-02-21. It is manufactured by Beijing Demax Medical Technology Co.,Ltd. The 510(k) number is K222184.
When was Introducer Sheath Kits approved by the FDA?
Introducer Sheath Kits received FDA 510(k) clearance on 2023-02-21, under approval number K222184.
What company makes Introducer Sheath Kits?
Introducer Sheath Kits is manufactured by Beijing Demax Medical Technology Co.,Ltd.
What is the FDA product code for Introducer Sheath Kits?
The FDA product code for Introducer Sheath Kits 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.