Aventus Introducer Sheath
K-Number: K260091 · 2026-04-13
ApplicantInquis Medical
Decision Date2026-04-13
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Aventus Introducer Sheath is a medical device manufactured by Inquis Medical. It received FDA 510(k) clearance on 2026-04-13 under approval number K260091. 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 Aventus Introducer Sheath?
Aventus Introducer Sheath is a medical device that received FDA 510(k) clearance on 2026-04-13. It is manufactured by Inquis Medical. The 510(k) number is K260091.
When was Aventus Introducer Sheath approved by the FDA?
Aventus Introducer Sheath received FDA 510(k) clearance on 2026-04-13, under approval number K260091.
What company makes Aventus Introducer Sheath?
Aventus Introducer Sheath is manufactured by Inquis Medical.
What is the FDA product code for Aventus Introducer Sheath?
The FDA product code for Aventus Introducer Sheath is DYB.
Other Devices by Inquis Medical
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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.