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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 K181150
Device Name ProtekDuo Mini Veno-Venous Cannula Set
Applicant
Cardiacassist, Inc.
240 Alpha Dr.
Pittsburgh,  PA  15238
Applicant Contact Greg Johnson
Correspondent
Cardiacassist, Inc.
240 Alpha Dr.
Pittsburgh,  PA  15238
Correspondent Contact Greg Johnson
Regulation Number870.4210
Classification Product Code
DWF  
Date Received05/01/2018
Decision Date 05/25/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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