Cleared Traditional

VIALOK SINGLE VIAL ACCESS DEVICE VENTED

K122265 · Yukon Medical, LLC · General Hospital
Aug 2012
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K122265 is an FDA 510(k) clearance for the VIALOK SINGLE VIAL ACCESS DEVICE 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 August 14, 2012, 15 days after receiving the submission on July 30, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K122265 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2012
Decision Date August 14, 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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