Cleared Traditional

K120424 - MEDSOURCE IV ADMINSTRATION SET (FDA 510(k) Clearance)

K120424 · Medsource International, LLC · General Hospital

Jul 2012

Decision

149d

Days

Class 2

Risk

K120424 is an FDA 510(k) clearance for the MEDSOURCE IV ADMINSTRATION SET. This device is classified as a Set, I.v. Fluid Transfer (Class II - Special Controls, product code LHI).

Submitted by Medsource International, LLC (Mound, US). The FDA issued a Cleared decision on July 11, 2012, 149 days after receiving the submission on February 13, 2012.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K120424 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 13, 2012
Decision Date	July 11, 2012
Days to Decision	149 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF