Cleared Traditional

Sapphire Sets

K171346 · Icu Medical · General Hospital
Aug 2017
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K171346 is an FDA 510(k) clearance for the Sapphire Sets, a Accessories, Pump, Infusion (Class II — Special Controls, product code MRZ), submitted by Icu Medical (Lake Forest, US). The FDA issued a Cleared decision on August 25, 2017, 109 days after receiving the submission on May 8, 2017. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number K171346 FDA.gov
FDA Decision Cleared SESE
Date Received May 08, 2017
Decision Date August 25, 2017
Days to Decision 109 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code MRZ — Accessories, Pump, Infusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5725