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FDA 510(k)

AcQCross Qx Integrated Transseptal Dilator/Needle

K-Number: K210685 · 2021-04-06

ApplicantAcutus Medical, Inc.
Decision Date2021-04-06
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AcQCross Qx Integrated Transseptal Dilator/Needle is a medical device manufactured by Acutus Medical, Inc.. It received FDA 510(k) clearance on 2021-04-06 under approval number K210685. 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 AcQCross Qx Integrated Transseptal Dilator/Needle?

AcQCross Qx Integrated Transseptal Dilator/Needle is a medical device that received FDA 510(k) clearance on 2021-04-06. It is manufactured by Acutus Medical, Inc.. The 510(k) number is K210685.

When was AcQCross Qx Integrated Transseptal Dilator/Needle approved by the FDA?

AcQCross Qx Integrated Transseptal Dilator/Needle received FDA 510(k) clearance on 2021-04-06, under approval number K210685.

What company makes AcQCross Qx Integrated Transseptal Dilator/Needle?

AcQCross Qx Integrated Transseptal Dilator/Needle is manufactured by Acutus Medical, Inc..

What is the FDA product code for AcQCross Qx Integrated Transseptal Dilator/Needle?

The FDA product code for AcQCross Qx Integrated Transseptal Dilator/Needle is DYB.

Related Clinical Trials

NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING NCT07515040 Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- Guidance RECRUITING

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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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