STERI-CATH MDI— 510(k) K923559

Substantially Equivalent

Concord/Portex

FDA 510(k) clearance K923559 for STERI-CATH MDI, Substantially Equivalent on 1993-10-25. Applicant: Concord/Portex.

Clearance details

Applicant: Concord/Portex
Product code: Code CAF
Advisory panel: Anesthesiology
Date received: 1992-07-17
Decision date: 1993-10-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, 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.