Cleared Special

UNIVERSAL VIAL ACCESS SPIKE

K080989 · Icu Medical, Inc. · General Hospital
May 2008
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K080989 is an FDA 510(k) clearance for the UNIVERSAL VIAL ACCESS SPIKE, a Syringe, Piston (Class II — Special Controls, product code FMF), submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on May 2, 2008, 25 days after receiving the submission on April 7, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5860.

Submission Details

510(k) Number K080989 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 2008
Decision Date May 02, 2008
Days to Decision 25 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMF — Syringe, Piston
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5860

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