Cleared Traditional

Multi-Sideport Catheter Infusion Set

K182071 · Cook Incorporated · Cardiovascular
Apr 2019
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K182071 is an FDA 510(k) clearance for the Multi-Sideport Catheter Infusion Set, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on April 25, 2019, 267 days after receiving the submission on August 1, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number K182071 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2018
Decision Date April 25, 2019
Days to Decision 267 days
Submission Type Traditional
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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