HAEMONETICS 40U RBC FILTER BAG— 510(k) K061103

Substantially Equivalent

Haemonetics Corp.

FDA 510(k) clearance K061103 for HAEMONETICS 40U RBC FILTER BAG, Substantially Equivalent on 2006-05-17. Applicant: Haemonetics Corp..

Clearance details

Applicant: Haemonetics Corp.
Product code: Code CAK
Advisory panel: General Hospital
Date received: 2006-04-20
Decision date: 2006-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Braintree, MA, US

Download summary PDF View on FDA.gov ↗

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.