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FDA 510(k) Application Details - K152161
Device Classification Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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510(K) Number
K152161
Device Name
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant
Thoratec Corporation
6035 Stoneridge Drive
Pleasanton, CA 94588 US
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Contact
Lori DonDiego
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Regulation Number
870.4210
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Classification Product Code
DWF
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Date Received
08/03/2015
Decision Date
09/18/2015
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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