SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE— 510(k) K855064

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K855064 for SWANK BLOOD TRANSFUSION MICRO-FILTER W/STRAIGHT SE, Substantially Equivalent on 1986-03-12. Applicant: Cobe Laboratories, Inc..

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code CAK
Advisory panel: General Hospital
Date received: 1985-12-18
Decision date: 1986-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

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Adverse events under product code CAK

product code CAK

Malfunction: 476
Total: 476

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.