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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Acutus Medical, Inc.. It received FDA 510(k) clearance on 2023-12-17 under 510(k) 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. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K233691.

When did FlexCath Cross Transseptal Solution receive FDA 510(k) clearance?

FlexCath Cross Transseptal Solution received FDA 510(k) clearance on 2023-12-17, under 510(k) number K233691.

Who is the listed applicant for FlexCath Cross Transseptal Solution?

The FDA 510(k) record lists Acutus Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FlexCath Cross Transseptal Solution?

The FDA product code for FlexCath Cross Transseptal Solution is DYB.

Other records listing Acutus Medical, Inc. as applicant

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Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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