Intri24 Introducer Sheath (52-101)
K-Number: K233646 · 2023-12-12
ApplicantInari Medical, Inc.
Decision Date2023-12-12
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Intri24 Introducer Sheath (52-101) is a medical device manufactured by Inari Medical, Inc.. It received FDA 510(k) clearance on 2023-12-12 under approval number K233646. 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 Intri24 Introducer Sheath (52-101)?
Intri24 Introducer Sheath (52-101) is a medical device that received FDA 510(k) clearance on 2023-12-12. It is manufactured by Inari Medical, Inc.. The 510(k) number is K233646.
When was Intri24 Introducer Sheath (52-101) approved by the FDA?
Intri24 Introducer Sheath (52-101) received FDA 510(k) clearance on 2023-12-12, under approval number K233646.
What company makes Intri24 Introducer Sheath (52-101)?
Intri24 Introducer Sheath (52-101) is manufactured by Inari Medical, Inc..
What is the FDA product code for Intri24 Introducer Sheath (52-101)?
The FDA product code for Intri24 Introducer Sheath (52-101) 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.