Cleared Traditional

ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE

K090189 · Icu Medical, Inc. · General Hospital
Apr 2009
Decision
74d
Days
Class 2
Risk

About This 510(k) Submission

K090189 is an FDA 510(k) clearance for the ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 10, 2009, 74 days after receiving the submission on January 26, 2009. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K090189 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2009
Decision Date April 10, 2009
Days to Decision 74 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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