Cleared Special

ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES

K082836 · Icu Medical, Inc. · General Hospital
Feb 2009
Decision
152d
Days
Class 2
Risk

About This 510(k) Submission

K082836 is an FDA 510(k) clearance for the ICU MEDICAL UNIVERSAL SINGLE-USE SPIKES, 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 25, 2009, 152 days after receiving the submission on September 26, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K082836 FDA.gov
FDA Decision Cleared SESE
Date Received September 26, 2008
Decision Date February 25, 2009
Days to Decision 152 days
Submission Type Special
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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