Cleared Traditional

SMARTSITE VIALSHIELD

K132863 · Yukon Medical, LLC · General Hospital
Oct 2013
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K132863 is an FDA 510(k) clearance for the SMARTSITE VIALSHIELD, a Set, I.v. Fluid Transfer (Class II — Special Controls, product code LHI), submitted by Yukon Medical, LLC (Durham, US). The FDA issued a Cleared decision on October 4, 2013, 22 days after receiving the submission on September 12, 2013. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K132863 FDA.gov
FDA Decision Cleared SESE
Date Received September 12, 2013
Decision Date October 04, 2013
Days to Decision 22 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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