Cleared Traditional

HIGH PRESSURE SETS-400 PSI

K100576 · Icu Medical, Inc. · General Hospital
Dec 2010
Decision
291d
Days
Class 2
Risk

About This 510(k) Submission

K100576 is an FDA 510(k) clearance for the HIGH PRESSURE SETS-400 PSI, 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 December 17, 2010, 291 days after receiving the submission on March 1, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K100576 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 2010
Decision Date December 17, 2010
Days to Decision 291 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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