AcQMap 3D Imaging and Mapping Catheter, Model 900009
K-Number: K210766 · 2022-06-21
ApplicantAcutus Medical, Inc.
Decision Date2022-06-21
Product CodeMTD
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
AcQMap 3D Imaging and Mapping Catheter, Model 900009 is a medical device manufactured by Acutus Medical, Inc.. It received FDA 510(k) clearance on 2022-06-21 under approval number K210766. 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, Model 900009?
AcQMap 3D Imaging and Mapping Catheter, Model 900009 is a medical device that received FDA 510(k) clearance on 2022-06-21. It is manufactured by Acutus Medical, Inc.. The 510(k) number is K210766.
When was AcQMap 3D Imaging and Mapping Catheter, Model 900009 approved by the FDA?
AcQMap 3D Imaging and Mapping Catheter, Model 900009 received FDA 510(k) clearance on 2022-06-21, under approval number K210766.
What company makes AcQMap 3D Imaging and Mapping Catheter, Model 900009?
AcQMap 3D Imaging and Mapping Catheter, Model 900009 is manufactured by Acutus Medical, Inc..
What is the FDA product code for AcQMap 3D Imaging and Mapping Catheter, Model 900009?
The FDA product code for AcQMap 3D Imaging and Mapping Catheter, Model 900009 is MTD.
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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.