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FDA 510(k) Application Details - K160257
Device Classification Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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510(K) Number
K160257
Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant
CARDIAC ASSIST, INC.
240 ALPHA DRIVE
PITTSBURGH, PA 15238 US
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Contact
GREG JOHNSON
Other 510(k) Applications for this Contact
Regulation Number
870.4210
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Classification Product Code
DWF
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More FDA Info for this Product Code
Date Received
02/01/2016
Decision Date
03/04/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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