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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tubing, Pump, Cardiopulmonary Bypass
510(k) Number K142607
Device Name AngioVac Circuit
Applicant
ANGIODYNAMICS
26 FOREST STREET
MARLBOROUGH,  MA  01752
Applicant Contact Gary Barrett
Correspondent
ANGIODYNAMICS
26 FOREST STREET
MARLBOROUGH,  MA  01752
Correspondent Contact Gary Barrett
Regulation Number870.4390
Classification Product Code
DWE  
Date Received09/15/2014
Decision Date 12/11/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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