AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS— 510(k) K093773

Substantially Equivalent

Amsino International, Inc.

FDA 510(k) clearance K093773 for AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS, Substantially Equivalent on 2010-03-10. Applicant: Amsino International, Inc..

Clearance details

Applicant: Amsino International, Inc.
Product code: Code FPA
Advisory panel: General Hospital
Date received: 2009-12-08
Decision date: 2010-03-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Pomona, CA, US

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Adverse events under product code FPA

product code FPA

Death: 95
Injury: 14,421
Malfunction: 125,815
Other: 30
Total: 140,361

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.