COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM— 510(k) K042473

Substantially Equivalent

Cobe Cardiovascular, Inc.

FDA 510(k) clearance K042473 for COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM, Substantially Equivalent on 2004-11-19. Applicant: Cobe Cardiovascular, Inc..

Clearance details

Applicant: Cobe Cardiovascular, Inc.
Product code: Code JQC
Advisory panel: Clinical Chemistry
Date received: 2004-09-13
Decision date: 2004-11-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Arvada, CO, US

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Adverse events under product code JQC

product code JQC

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.