Intri24 Sheath
K-Number: K212392 · 2022-04-01
ApplicantInari Medical, Inc.
Decision Date2022-04-01
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Intri24 Sheath is a medical device manufactured by Inari Medical, Inc.. It received FDA 510(k) clearance on 2022-04-01 under approval number K212392. 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 Sheath?
Intri24 Sheath is a medical device that received FDA 510(k) clearance on 2022-04-01. It is manufactured by Inari Medical, Inc.. The 510(k) number is K212392.
When was Intri24 Sheath approved by the FDA?
Intri24 Sheath received FDA 510(k) clearance on 2022-04-01, under approval number K212392.
What company makes Intri24 Sheath?
Intri24 Sheath is manufactured by Inari Medical, Inc..
What is the FDA product code for Intri24 Sheath?
The FDA product code for Intri24 Sheath 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.