APRO 55 Catheter and Alembic Aspiration Tubing— 510(k) K232971

Substantially Equivalent

Alembic, LLC

FDA 510(k) clearance K232971 for APRO 55 Catheter and Alembic Aspiration Tubing, Substantially Equivalent on 2024-02-29. Applicant: Alembic, LLC.

Clearance details

Applicant: Alembic, LLC
Product code: Code NRY
Advisory panel: Cardiovascular
Date received: 2023-09-21
Decision date: 2024-02-29
Decision: Substantially Equivalent
Clearance type: Traditional
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.