Cleared Traditional

AngioVac Circuit

K142607 · Angiodynamics · Cardiovascular

Dec 2014

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K142607 is an FDA 510(k) clearance for the AngioVac Circuit, a Tubing, Pump, Cardiopulmonary Bypass (Class II — Special Controls, product code DWE), submitted by Angiodynamics (Marlborough, US). The FDA issued a Cleared decision on December 11, 2014, 87 days after receiving the submission on September 15, 2014. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4390.

Submission Details

510(k) Number	K142607 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 2014
Decision Date	December 11, 2014
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF