Cleared Traditional

VIALOK NON-VENTED

K121182 · Yukon Medical, LLC · General Hospital
May 2012
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K121182 is an FDA 510(k) clearance for the VIALOK NON-VENTED, 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 May 3, 2012, 15 days after receiving the submission on April 18, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K121182 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2012
Decision Date May 03, 2012
Days to Decision 15 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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