APRO 55 Swift Catheter and Alembic Aspiration Tubing— 510(k) K250958

Substantially Equivalent

Alembic, LLC

FDA 510(k) clearance K250958 for APRO 55 Swift Catheter and Alembic Aspiration Tubing, Substantially Equivalent on 2025-04-28. Applicant: Alembic, LLC.

Clearance details

Applicant: Alembic, LLC
Product code: Code NRY
Advisory panel: Cardiovascular
Date received: 2025-03-31
Decision date: 2025-04-28
Decision: Substantially Equivalent
Clearance type: Special
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NRY

product code NRY

Death: 411
Injury: 1,712
Malfunction: 1,855
Total: 3,978

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.