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FDA 510(k)

AcQMap 3D Imaging and Mapping Catheter

K-Number: K201341 · 2020-09-15

ApplicantAcutus Medical, Inc.
Decision Date2020-09-15
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AcQMap 3D Imaging and Mapping Catheter is a medical device manufactured by Acutus Medical, Inc.. It received FDA 510(k) clearance on 2020-09-15 under approval number K201341. The device is classified under product code MTD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AcQMap 3D Imaging and Mapping Catheter?

AcQMap 3D Imaging and Mapping Catheter is a medical device that received FDA 510(k) clearance on 2020-09-15. It is manufactured by Acutus Medical, Inc.. The 510(k) number is K201341.

When was AcQMap 3D Imaging and Mapping Catheter approved by the FDA?

AcQMap 3D Imaging and Mapping Catheter received FDA 510(k) clearance on 2020-09-15, under approval number K201341.

What company makes AcQMap 3D Imaging and Mapping Catheter?

AcQMap 3D Imaging and Mapping Catheter is manufactured by Acutus Medical, Inc..

What is the FDA product code for AcQMap 3D Imaging and Mapping Catheter?

The FDA product code for AcQMap 3D Imaging and Mapping Catheter is MTD.

Related Clinical Trials

NCT01254474 Evaluation of Depolarization and Repolarisation Activity During Cardiac Arrhythmia Using a Novel Monophasic Action Potential Catheter COMPLETED NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT06510556 Feasibility Study of the FARAFLEX Mapping and PFA System RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT05225935 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia COMPLETED NCT07552272 Hummingbird ICE Study NOT_YET_RECRUITING

Related PubMed Literature

PMID: 42204020 A Minimal UDI-DICOM Mapping Profile and Validation Artifact for Medical-Device Imaging Workflows. Journal of imaging informatics in medicine (2026)

Other Devices by Acutus Medical, Inc.

K170948AcQMap High Resolution Imaging and Mapping System K170819AcQMap 3D Imaging and Mapping Catheter K162925AcQGuide Steerable Sheath K171557AcQRef Introducer Sheath K191392AcQMap High Resolution Imaging and Mapping System K192106AcQRef Introducer Sheath

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Related Devices (Code: MTD)

K153093FIRMap CatheterAbbott Electrophysiology K170819AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc. K163709FIRMap CatheterAbbott Electrophysiology K172393Advisor HD Grid Mapping Catheter, Sensor EnabledSt. Jude Medical, Inc. K200212Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledInnovative Health, LLC K201750Pentaray Nav eco High-Density Mapping CatheterBiosense Webster, Inc.

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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