Cleared Traditional

Guarded Luer Connector

K173577 · International Medical Industries, Inc. · General Hospital
Jun 2018
Decision
199d
Days
Class 2
Risk

About This 510(k) Submission

K173577 is an FDA 510(k) clearance for the Guarded Luer Connector, a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI), submitted by International Medical Industries, Inc. (Pompano Beach, US). The FDA issued a Cleared decision on June 7, 2018, 199 days after receiving the submission on November 20, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K173577 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2017
Decision Date June 07, 2018
Days to Decision 199 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LHI — Set, I.v. Fluid Transfer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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