CATHETER, UMBILICAL, VICRA— 510(k) K771891

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K771891 for CATHETER, UMBILICAL, VICRA, Substantially Equivalent on 1977-11-02. Applicant: Travenol Laboratories, S.A..

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code FOS
Advisory panel: General Hospital
Date received: 1977-10-06
Decision date: 1977-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FOS

product code FOS

Death: 12
Other: 1
Total: 13

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.