Cleared Special

SPINNING SPIROS, MODEL CH-2000

K082806 · Icu Medical, Inc. · General Hospital
Apr 2009
Decision
194d
Days
Class 2
Risk

About This 510(k) Submission

K082806 is an FDA 510(k) clearance for the SPINNING SPIROS, MODEL CH-2000, 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 6, 2009, 194 days after receiving the submission on September 24, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K082806 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 2008
Decision Date April 06, 2009
Days to Decision 194 days
Submission Type Special
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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