RADIATION STERILIZED SUCTION CATHETERS— 510(k) K820109

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K820109 for RADIATION STERILIZED SUCTION CATHETERS, Substantially Equivalent on 1982-01-29. Applicant: Travenol Laboratories, S.A..

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code BSY
Advisory panel: Anesthesiology
Date received: 1982-01-15
Decision date: 1982-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.