Talon Transseptal Sheath
K-Number: K231108 · 2023-09-27
ApplicantInari Medical, Inc.
Decision Date2023-09-27
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Talon Transseptal Sheath is a medical device manufactured by Inari Medical, Inc.. It received FDA 510(k) clearance on 2023-09-27 under approval number K231108. 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 Talon Transseptal Sheath?
Talon Transseptal Sheath is a medical device that received FDA 510(k) clearance on 2023-09-27. It is manufactured by Inari Medical, Inc.. The 510(k) number is K231108.
When was Talon Transseptal Sheath approved by the FDA?
Talon Transseptal Sheath received FDA 510(k) clearance on 2023-09-27, under approval number K231108.
What company makes Talon Transseptal Sheath?
Talon Transseptal Sheath is manufactured by Inari Medical, Inc..
What is the FDA product code for Talon Transseptal Sheath?
The FDA product code for Talon Transseptal 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.