COBE HEMOFLO BLOOD TUBING SETS— 510(k) K801211

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K801211 for COBE HEMOFLO BLOOD TUBING SETS, Substantially Equivalent on 1980-07-14. Applicant: Cobe Laboratories, Inc..

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code FJK
Advisory panel: Gastroenterology, Urology
Date received: 1980-05-20
Decision date: 1980-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code FJK

product code FJK

Death: 52
Malfunction: 3,430
Total: 3,482

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.