Thinline Sheath Introducer
K-Number: K232260 · 2023-09-27
ApplicantInneuroco, Inc.
Decision Date2023-09-27
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Thinline Sheath Introducer is a medical device manufactured by Inneuroco, Inc.. It received FDA 510(k) clearance on 2023-09-27 under approval number K232260. 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 Thinline Sheath Introducer?
Thinline Sheath Introducer is a medical device that received FDA 510(k) clearance on 2023-09-27. It is manufactured by Inneuroco, Inc.. The 510(k) number is K232260.
When was Thinline Sheath Introducer approved by the FDA?
Thinline Sheath Introducer received FDA 510(k) clearance on 2023-09-27, under approval number K232260.
What company makes Thinline Sheath Introducer?
Thinline Sheath Introducer is manufactured by Inneuroco, Inc..
What is the FDA product code for Thinline Sheath Introducer?
The FDA product code for Thinline Sheath Introducer 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.