Cleared Traditional

ARISURE NEUTRAL VALVE

K120799 · Yukon Medical, LLC · General Hospital
Mar 2012
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K120799 is an FDA 510(k) clearance for the ARISURE NEUTRAL VALVE, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Yukon Medical, LLC (Durham, US). The FDA issued a Cleared decision on March 30, 2012, 14 days after receiving the submission on March 16, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K120799 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2012
Decision Date March 30, 2012
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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