Cleared Traditional

ROTATING ADAPTERS

K140475 · Merit Medical Systems, Inc. · Cardiovascular

Apr 2014

Decision

49d

Days

Class 2

Risk

About This 510(k) Submission

K140475 is an FDA 510(k) clearance for the ROTATING ADAPTERS, a Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (Class II — Special Controls, product code DTL), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on April 16, 2014, 49 days after receiving the submission on February 26, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4290.

Submission Details

510(k) Number	K140475 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 26, 2014
Decision Date	April 16, 2014
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.4290