AcQGuide MAX Steerable Sheath— 510(k) K211100

Substantially Equivalent

Acutus Medical, Inc.

FDA 510(k) clearance K211100 for AcQGuide MAX Steerable Sheath, Substantially Equivalent on 2021-05-14. Applicant: Acutus Medical, Inc..

Clearance details

Applicant: Acutus Medical, Inc.
Product code: Code DRA
Advisory panel: Cardiovascular
Date received: 2021-04-13
Decision date: 2021-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRA

product code DRA

Death: 156
Injury: 3,133
Malfunction: 6,266
Total: 9,555

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.