CATHETER, NASAL, OXYGEN— 510(k) K902420

Substantially Equivalent

Gainor Medical Europe, Ltd.

FDA 510(k) clearance K902420 for CATHETER, NASAL, OXYGEN, Substantially Equivalent on 1991-04-17. Applicant: Gainor Medical Europe, Ltd..

Clearance details

Applicant: Gainor Medical Europe, Ltd.
Product code: Code CAT
Advisory panel: Anesthesiology
Date received: 1990-05-31
Decision date: 1991-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mcdonough, GA, US

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Adverse events under product code CAT

product code CAT

Death: 5
Malfunction: 544
Other: 2
Total: 551

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.