Cleared Traditional

HLIC NEEDLE-LESS VALVE

K120548 · Health Line International Corporation · General Hospital
May 2012
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K120548 is an FDA 510(k) clearance for the HLIC NEEDLE-LESS VALVE, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Health Line International Corporation (Centerville, US). The FDA issued a Cleared decision on May 4, 2012, 71 days after receiving the submission on February 23, 2012. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K120548 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2012
Decision Date May 04, 2012
Days to Decision 71 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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