0.45% SODIUM CHLORIDE SOL./RESP. THERAPY— 510(k) K800294

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K800294 for 0.45% SODIUM CHLORIDE SOL./RESP. THERAPY, Substantially Equivalent on 1980-03-10. Applicant: Abbott Laboratories.

Clearance details

Applicant: Abbott Laboratories
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1980-02-11
Decision date: 1980-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

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Adverse events under product code CAF

product code CAF

Death: 22
Injury: 125
Malfunction: 613
Other: 11
Total: 771

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.