FlexCath Cross Transseptal Solution
K-Number: K233691 · 2023-12-17
ApplicantAcutus Medical, Inc.
Decision Date2023-12-17
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
FlexCath Cross Transseptal Solution is a medical device manufactured by Acutus Medical, Inc.. It received FDA 510(k) clearance on 2023-12-17 under approval number K233691. 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 FlexCath Cross Transseptal Solution?
FlexCath Cross Transseptal Solution is a medical device that received FDA 510(k) clearance on 2023-12-17. It is manufactured by Acutus Medical, Inc.. The 510(k) number is K233691.
When was FlexCath Cross Transseptal Solution approved by the FDA?
FlexCath Cross Transseptal Solution received FDA 510(k) clearance on 2023-12-17, under approval number K233691.
What company makes FlexCath Cross Transseptal Solution?
FlexCath Cross Transseptal Solution is manufactured by Acutus Medical, Inc..
What is the FDA product code for FlexCath Cross Transseptal Solution?
The FDA product code for FlexCath Cross Transseptal Solution 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.