Cleared Traditional

FENWAL 40 MICRON TRANSFUSION FILTER

K972159 · Baxter Healthcare Corp · General Hospital
Jul 1997
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K972159 is an FDA 510(k) clearance for the FENWAL 40 MICRON TRANSFUSION FILTER, 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 July 23, 1997, 44 days after receiving the submission on June 9, 1997. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K972159 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 1997
Decision Date July 23, 1997
Days to Decision 44 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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