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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 the device name listed in this FDA 510(k) record. The listed applicant is Acutus Medical, Inc.. It received FDA 510(k) clearance on 2020-09-15 under 510(k) 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. The listed applicant is Acutus Medical, Inc.. The 510(k) number is K201341.

When did AcQMap 3D Imaging and Mapping Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for AcQMap 3D Imaging and Mapping Catheter?

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 AcQMap 3D Imaging and Mapping Catheter?

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

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

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Related Devices (Code: MTD)

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.

K261012OptiMap Catheter - 60mm (OPTI-CATH2-60)Cortex, Inc.K253205OptiMap Catheter - 50mm (OPTI-CATH2-50)Cortex, Inc.K233433Sphere-9Dx Diagnostic Catheter (AFR-00009)MedtronicK241372Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ABBOTT MEDICALK231312PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto IDBiosense Webster, Inc.K223666Ablacath™ Mapping CatheterAblacon, 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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