ASTOFLO— 510(k) K020060

Substantially Equivalent

Nats Corp.

FDA 510(k) clearance K020060 for ASTOFLO, Substantially Equivalent on 2002-03-05. Applicant: Nats Corp..

Clearance details

Applicant: Nats Corp.
Product code: Code BSB
Advisory panel: Hematology
Date received: 2002-01-08
Decision date: 2002-03-05
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Sound Beach, NY, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSB

product code BSB

Death: 5
Malfunction: 1,778
Total: 1,783

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.