Cleared Traditional

SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET

K022477 · Summit Medical , Ltd. · General Hospital
Oct 2002
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K022477 is an FDA 510(k) clearance for the SUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSION FILTER WITH ADMINISTRATION SET, a Microfilter, Blood Transfusion (Class II — Special Controls, product code CAK), submitted by Summit Medical , Ltd. (Stevenage Hertfordshire, GB). The FDA issued a Cleared decision on October 25, 2002, 88 days after receiving the submission on July 29, 2002. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K022477 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2002
Decision Date October 25, 2002
Days to Decision 88 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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