Intri26 Introducer Sheath
K-Number: K252508 · 2025-12-17
ApplicantInari Medical, Inc.
Decision Date2025-12-17
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Intri26 Introducer Sheath is a medical device manufactured by Inari Medical, Inc.. It received FDA 510(k) clearance on 2025-12-17 under approval number K252508. 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 Intri26 Introducer Sheath?
Intri26 Introducer Sheath is a medical device that received FDA 510(k) clearance on 2025-12-17. It is manufactured by Inari Medical, Inc.. The 510(k) number is K252508.
When was Intri26 Introducer Sheath approved by the FDA?
Intri26 Introducer Sheath received FDA 510(k) clearance on 2025-12-17, under approval number K252508.
What company makes Intri26 Introducer Sheath?
Intri26 Introducer Sheath is manufactured by Inari Medical, Inc..
What is the FDA product code for Intri26 Introducer Sheath?
The FDA product code for Intri26 Introducer 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.