AcQMap 3D Imaging and Mapping Catheter, Model 900009— 510(k) K210766

Substantially Equivalent

Acutus Medical, Inc.

FDA 510(k) clearance K210766 for AcQMap 3D Imaging and Mapping Catheter, Model 900009, Substantially Equivalent on 2022-06-21. Applicant: Acutus Medical, Inc..

Clearance details

Applicant: Acutus Medical, Inc.
Product code: Code MTD
Advisory panel: Cardiovascular
Date received: 2021-03-15
Decision date: 2022-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MTD

product code MTD

Death: 22
Injury: 376
Malfunction: 986
Total: 1,384

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.