Cleared Traditional

HAEMONETICS 40U RBC FILTER BAG

K061103 · Haemonetics Corp. · General Hospital
May 2006
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K061103 is an FDA 510(k) clearance for the HAEMONETICS 40U RBC FILTER BAG, a Microfilter, Blood Transfusion (Class II — Special Controls, product code CAK), submitted by Haemonetics Corp. (Braintree, US). The FDA issued a Cleared decision on May 17, 2006, 27 days after receiving the submission on April 20, 2006. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K061103 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 2006
Decision Date May 17, 2006
Days to Decision 27 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code CAK — Microfilter, Blood Transfusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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