Cleared Traditional

CLAVE STOPCOCK

K080077 · Icu Medical, Inc. · General Hospital
Feb 2008
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K080077 is an FDA 510(k) clearance for the CLAVE STOPCOCK, a Stopcock, I.v. Set (Class II — Special Controls, product code FMG), submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 13, 2008, 33 days after receiving the submission on January 11, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K080077 FDA.gov
FDA Decision Cleared SESE
Date Received January 11, 2008
Decision Date February 13, 2008
Days to Decision 33 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMG — Stopcock, I.v. Set
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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