HEMAFLO BLOOD TUBING SETS— 510(k) K823092

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K823092 for HEMAFLO BLOOD TUBING SETS, Substantially Equivalent on 1982-11-22. Applicant: Cobe Laboratories, Inc..

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code FKQ
Advisory panel: Gastroenterology, Urology
Date received: 1982-10-20
Decision date: 1982-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FKQ

product code FKQ

Other: 1
Total: 1

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.