AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX— 510(k) K193509

Substantially Equivalent

Acutus Medical, Inc.

FDA 510(k) clearance K193509 for AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX, Substantially Equivalent on 2020-01-17. Applicant: Acutus Medical, Inc..

Clearance details

Applicant: Acutus Medical, Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2019-12-18
Decision date: 2020-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.