Cleared Traditional

CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX

K081361 · Icu Medical, Inc. · General Hospital
Aug 2008
Decision
105d
Days
Class 2
Risk

About This 510(k) Submission

K081361 is an FDA 510(k) clearance for the CHEMOCLAVE CYTOTOXIC MEDICATION PREPARATION AND DELIVERY SYSTEM, MODEL, CH-XXXX, 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 August 28, 2008, 105 days after receiving the submission on May 15, 2008. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K081361 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2008
Decision Date August 28, 2008
Days to Decision 105 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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