K251014

Substantially Equivalent

APRO 45 Catheter

Applicant: Alembic, LLC
Product code: DQY
Advisory panel: Cardiovascular
Date received: 2025-04-02
Decision date: 2025-05-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, CA, US

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.