Cleared Special

PULL TAB SQUEEZE FLUSH

K070979 · Icu Medical, Inc. · Cardiovascular
Sep 2007
Decision
166d
Days
Class 2
Risk

About This 510(k) Submission

K070979 is an FDA 510(k) clearance for the PULL TAB SQUEEZE FLUSH, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Icu Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 19, 2007, 166 days after receiving the submission on April 6, 2007. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number K070979 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 2007
Decision Date September 19, 2007
Days to Decision 166 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRA — Catheter, Continuous Flush
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1210

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