Cleared Special

Passage Hemostasis Valve

K143429 · Merit Medical Systems, Inc. · Cardiovascular

Dec 2014

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K143429 is an FDA 510(k) clearance for the Passage Hemostasis Valve, a Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (Class II — Special Controls, product code DTL), submitted by Merit Medical Systems, Inc. (Galway, IE). The FDA issued a Cleared decision on December 22, 2014, 21 days after receiving the submission on December 1, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4290.

Submission Details

510(k) Number	K143429 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 01, 2014
Decision Date	December 22, 2014
Days to Decision	21 days
Submission Type	Special
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