ASTOFLO— 510(k) K020060

Name: FDA 510(k) clearance K020060
Creator: U.S. Food and Drug Administration
Published: 2002-03-05

Substantially Equivalent

Nats Corp.

FDA 510(k) clearance K020060 for ASTOFLO, Substantially Equivalent on 2002-03-05. Applicant: Nats Corp.. Device class: 2.

Clearance details

Applicant: Nats Corp.
Product code: Code BSB
Device class: Class 2
Regulation: 21 CFR 864.9205
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 ↗

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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.