Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Acutus Medical, Inc.. It received FDA 510(k) clearance on 2021-04-06 under 510(k) 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. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K210685.

When did AcQCross Qx Integrated Transseptal Dilator/Needle receive FDA 510(k) clearance?

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

Who is the listed applicant for AcQCross Qx Integrated Transseptal Dilator/Needle?

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 AcQCross Qx Integrated Transseptal Dilator/Needle?

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

Other records listing Acutus Medical, Inc. as applicant

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.

K233691FlexCath Cross Transseptal SolutionK231091AcQMap High Resolution Imaging and Mapping SystemK230606AcQMap® High Resolution Imaging and Mapping SystemK222209AcQMap High Resolution Imaging and Mapping SystemK220784AcQMap High Resolution Imaging and Mapping SystemK210766AcQMap 3D Imaging and Mapping Catheter, Model 900009

View all 24 devices →

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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.

↑