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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(k) Number K113869
Device Name ORIGEN REINFORCED DUAL LUMEN CATHETER
Applicant
Origen Biomedical, Inc.
7000 BURLESON ROAD
BLDG D
AUSTIN,  TX  78744
Applicant Contact RICHARD MARTIN
Correspondent
Origen Biomedical, Inc.
7000 BURLESON ROAD
BLDG D
AUSTIN,  TX  78744
Correspondent Contact RICHARD MARTIN
Regulation Number870.4210
Classification Product Code
DWF  
Date Received12/30/2011
Decision Date 07/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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