Cleared Traditional

FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72

K982822 · Baxter Healthcare Corp · General Hospital
Sep 1998
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K982822 is an FDA 510(k) clearance for the FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72, a Microfilter, Blood Transfusion (Class II — Special Controls, product code CAK), submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on September 30, 1998, 50 days after receiving the submission on August 11, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K982822 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1998
Decision Date September 30, 1998
Days to Decision 50 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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