Cleared Traditional

CLAVE NEUTRON

K100434 · Icu Medical, Inc. · General Hospital
Jul 2010
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K100434 is an FDA 510(k) clearance for the CLAVE NEUTRON, 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 July 9, 2010, 143 days after receiving the submission on February 16, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K100434 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 2010
Decision Date July 09, 2010
Days to Decision 143 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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